Authorized Representative 🇳🇱 Netherlands Active

ARKRAY Europe, B.V.

SRN: NL-AR-000002056 · Prof. J.H. Bavincklaan 2, 1183 AT Amstelveen, Netherlands
Manufacturers
1
Devices
430
Certificates
1
PRRCs
2

Basic Information

Address
Prof. J.H. Bavincklaan 2, 1183 AT Amstelveen, Netherlands
Website
www.arkray.eu
VAT Number
NL813681431B01
Trade Register
34214240
EORI
NL81368143

Non-EU Manufacturers

Name
ARKRAY Factory, Inc.

Manufacturers

Certificates

Type Number
IVDD Annex IV (excluding sections 4, 6) V1 027591 0045

Devices

SpotChem EL 2 (SE-1530)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market

SpotChem D-Concept 2e (SD-4840)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market

SpotChem D-Concept 2c (SD-4830)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market

OSMO STATION 2 (OM-6070)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market·2 countries

GLUCOCARD W Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market·2 countries

GLUCOCARD W Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market·2 countries

GLUCOCARD W (GT-7210)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market·2 countries

GLUCOCARD S (GT-7110)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market·2 countries

PochetChem Printer

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·22 countries

GLUCOCARD S

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

WeCheck for S onyx

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market

Hemolysis Solution

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·7 countries

Centrifuge Cup (for D-Concept)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·15 countries

AutionIDaten (AE-4070)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·22 countries

AutionIDaten (AE-4070)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·22 countries

Cuvette (heparin)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·15 countries

Cuvette (heparin)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·15 countries

CONTROL DILUTION SET 80

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·22 countries

COLUMN UNIT 80

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·22 countries

COLUMN UNIT 80T

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·22 countries

HEMOLYSIS WASHING SOLUTION 80H

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·22 countries

HEMOLYSIS WASHING SOLUTION Lite H

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·22 countries

AUTION ELEVEN (AE-4020)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·18 countries

AUTION ELEVEN (AE-4020)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·18 countries

AUTION ELEVEN (AE-4020)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·18 countries

PocketChem UA (PU-4010)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·18 countries

PocketChem UA (PU-4010)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·18 countries

PocketChem UA (PU-4010)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·18 countries

Whole Blood Sample Tube

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·24 countries

Whole Blood Sample Tube

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·24 countries

Centrifuge Tube (for SPOTCHEM EZ)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·24 countries

HEMOLYSIS WASHING SOLUTION 90H

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·22 countries

DILUENT 90

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·22 countries

COLUMN UNIT 90

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·22 countries

PocketChem BA (PA-4140)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·20 countries

SPOTCHEM EL (SE-1520)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·23 countries

SPOTCHEM D-02 (SD-4810)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·15 countries

SPOTCHEM D-03 (SD-4820)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·15 countries

SPOTCHEM D-01 (SD-3810)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·15 countries

SPOTCHEM D-00 QR (SD-9811)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·15 countries

SPOTCHEM EZ (SP-4430)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·25 countries

ADAMS A1c (HA-8180T)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·16 countries

ADAMS A1c Lite (HA-8380V)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·16 countries

ADAMS A1c (HA-8180V)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·16 countries

GLUCOCARD W (GT-7210)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W (GT-7210)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W (GT-7210)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W (GT-7210)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W (GT-7210)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W (GT-7210)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S (GT-7110)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S (GT-7110)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S (GT-7110)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S (GT-7110)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S (GT-7110)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S (GT-7110)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD W Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

CONTROL DILUTION SET 80

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

HEMOLYSIS WASHING SOLUTION 80H

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80CT

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80CV

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80B

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80A

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

COLUMN UNIT 80T

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

COLUMN UNIT 80

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Sticks 10EA

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

Uriflet S 9UB

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

GLUCOCARD SM (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD SM TEST STRIPS

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD SM TEST STRIPS

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD G sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD G sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD SM TEST STRIPS

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD G sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D-00 (SD-9810)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION MAX (AX-4030)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

OSMO STATION (OM-6050)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

OSMO STATION (OM-6050)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

OSMO STATION (OM-6050)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

GLUCOCARD SM (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

ADAMS A1c (HA-8180)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM i-Pack CRP Wide

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

GLUCOCARD SM CONTROL

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD 01 SENSOR

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD Σ Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD Vital Test Strips 

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD Σ Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD Vital (GT-1050)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD 01 SENSOR

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD 01 CONTROL

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD 01 CONTROL

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD 01 CONTROL

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-meter CONTROL

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-meter CONTROL

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-meter CONTROL

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S (GT-7110)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S (GT-7110)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Test Strips

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S (GT-7110)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S (GT-7110)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-meter (GT-1910)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-meter (GT-1910)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD SM TEST STRIPS

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD SM TEST STRIPS

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD SM TEST STRIPS

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-mini plus (GT-1960)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S Control Solution

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-mini plus (GT-1960)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-mini plus (GT-1960)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-mini plus (GT-1960)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-mini plus (GT-1960)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-mini plus (GT-1960)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD S onyx (GT-7120)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-mini plus (GT-1960)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD MX CONTROL

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD MX CONTROL

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-mini plus (GT-1960)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-mini plus (GT-1960)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD X-mini plus (GT-1960)

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD SM CONTROL

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD G sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

W0101060101

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

GLUCOCARD G sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

SPOTCHEM EZ (SP-4430)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM EZ (SP-4430)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II PANEL-V2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II PANEL-V2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Kidney-3

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Kidney-3

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Creatinine2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Creatinine2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Amy-wide

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II PANEL-V

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II PANEL-V

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II KENSHIN-2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Kidney-2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Kidney-2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM CALIBRATOR KIT

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM CALIBRATION CHECK

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION EYE Sheath Solution

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·8 countries

AUTION EYE Sheath Solution

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·9 countries

AUTION EYE Sheath Solution

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·9 countries

AUTION EYE Sheath Solution

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·9 countries

AUTION EYE Sheath Solution

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·4 countries

AUTION EYE Sheath Solution

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·13 countries

AUTION EYE Sheath Solution

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·13 countries

AUTION EYE Sheath Solution

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·4 countries

ADAMS A1c (HA-8190V)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·16 countries

Concentrated Washing Solution 3

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·4 countries

Concentrated Washing Solution 3

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·12 countries

Concentrated Washing Solution 3

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·7 countries

Concentrated Washing Solution 3

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·7 countries

Washing Solution (Concentrate)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·3 countries

Washing Solution (Concentrate)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·4 countries

Washing Solution (Concentrate)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·12 countries

Washing Solution (Concentrate)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·2 countries

The Lab 004 (DB-3910)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market

The Lab 001 (CE-8810)

Device
EU IVDR · Eu Ivd Class A ·ARKRAY Factory, Inc.·On the market·23 countries

SPOTCHEM II Heart-2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Heart-2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II PANEL-2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II PANEL-2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II PANEL-1

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II PANEL-1

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II STAT-1

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II STAT-1

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Liver-1

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Liver-1

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II HDL-Cholesterol (Direct Method)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II HDL-Cholesterol (Direct Method)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Magnesium

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Magnesium

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Inorganic Phosphorus

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Inorganic Phosphorus

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Fructosamine

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Fructosamine

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Creatinine

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Creatinine

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II ALP

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II ALP

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II GGT

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II GGT

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Amylase

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II CPK

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Amylase

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II CPK

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II LDH

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II LDH

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II GPT/ALT

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II GPT/ALT

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II GOT/AST

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

OSMO STATION Control Solution Set

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

The Lab 004 Urea/BUN

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Panel-E

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Panel-D

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Panel-C

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D-02 SET

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D-03 SET

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D-03 (SD-4820)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D-01 SET

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D-02 (SD-4810)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

Uriflet S 9HA

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

Uriflet S 10HB

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION SCREEN Microalbumin/Creatinine

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Sticks 10V

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Sticks 10PA

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Sticks 10EA

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Sticks 10EA

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Sticks 10PA

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

Uriflet S 9UB

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

Uriflet S 11UA

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II GOT/AST

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Albumin

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Albumin

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

COLUMN UNIT-HSVI-TP

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Total Protein

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Total Protein

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

COLUMN UNIT-HSVI-VP

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Calcium

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

CALIBRATOR 90

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

DILUENT 90

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

HEMOLYSIS WASHING SOLUTION 90H

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 90CV-S

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 90CV

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 90B

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Calcium

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 90A

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Total Bilirubin

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

COLUMN UNIT 90

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Total Bilirubin

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Blood Urea Nitrogen

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Blood Urea Nitrogen

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ADAMS A1c (HA-8190V)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Triglyceride

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Triglyceride

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

CONTROL DILUTION SET 80

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Total Cholesterol

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Total Cholesterol

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

HEMOLYSIS WASHING SOLUTION 80H

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Uric Acid

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80CT

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80CV

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80B

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Uric Acid

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Glucose

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Glucose

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80A

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

COLUMN UNIT 80T

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

COLUMN UNIT 80

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Screening

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Liver-D

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Stat2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Panel-V2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Total-A2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Metabolic2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Kidney2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D CRE2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Total-B

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Liver

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D UN

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D UA

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D TP

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D TG

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D TC

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D T-BIL

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Mg

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D LD

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D IP

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

CALIBRATOR Lite

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

HEMOLYSIS WASHING SOLUTION Lite H

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

CALIBRATOR 80

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

CONTROL DILUTION SET 80

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80CT

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80CV

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D HDL

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80B

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D GLU

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

HEMOLYSIS WASHING SOLUTION 80H

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D GGT

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ELUENT 80A

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D FRA

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D CK

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

COLUMN UNIT 80T

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Ca

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D AST (GOT)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D AMY

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

COLUMN UNIT 80

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ADAMS A1c (HA-8380V)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D ALT (GPT)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ADAMS A1c (HA-8180T)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D ALP

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ADAMS A1c (HA-8180T)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ADAMS A1c (HA-8180V)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ADAMS A1c (HA-8180V)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

The Lab 004 Ca

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D ALB

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Electrolyte (Na, K, Cl)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D CRP

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Control

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D Calibrator Kit

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Control Solution

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Diluent (BAC)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Diluent (SED)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Staining Solution (BAC)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Sheath Solution

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION Staining Solution (SED)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION MAX (AX-4030)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION MAX (AX-4030)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

Uriflet S 10HA

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION EYE Sheath Solution

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION EYE Control Solution

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION EYE Calibrator

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION EYE (AI-4510)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

Concentrated Washing Solution 3

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D-01 (SD-3810)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

S.G. Calibrator H

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

The Lab 004 AST (GOT)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION CHECK Plus

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

The Lab 004 ALT (GPT)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

The Lab 004 UA

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

Uriflet S 9UB

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AutionIDaten (AE-4070)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

PocketChem UA (PU-4010)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

PocketChem UA (PU-4010)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION ELEVEN (AE-4020)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION MAX (AX-4060)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

PocketChem UA (PU-4010)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

PocketChem UA (PU-4010)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

PocketChem UA (PU-4010)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION ELEVEN (AE-4020)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION ELEVEN (AE-4020)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION MAX (AX-4060)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AUTION MAX (AX-4060)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D-00 QR (SD-9811)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

The Lab 004 CRE

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

AMMONIA TEST KIT II

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

PocketChem BA (PA-4140)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

PocketChem BA (PA-4140)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM Electrolyte Control [Na, K, Cl]

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM E-Plate

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM EL (SE-1520)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM EL (SE-1520)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

The Lab 004 (DB-3910)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

Lactate Pro 2 (LT-1730)

Device
EU IVDD · Eu Ivd Self Testing ·ARKRAY Factory, Inc.·On the market

SPOTCHEM EL (SE-1520)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

A1C HD CONTROL

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

The Lab 001 A1C HD

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

The Lab 001 (CE-8810)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

Standard Solution Set

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

Washing Solution (Concentration)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

OSMO STATION (OM-6060)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

OSMO STATION (OM-6060)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

OSMO STATION (OM-6060)

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market·0 countries

Lactate Pro 2 Test Strip

Device
EU IVDD · Eu Ivd Self Testing ·ARKRAY Factory, Inc.·On the market

SPOTCHEM D AMY2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Amylase2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

GLUCOCARD G sensor

Device
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·On the market

SPOTCHEM II Calcium2

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market

ADAMS A1C CONTROL

Device
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·On the market·2 countries

Lactate Pro 2 Test Strip

Device
EU IVDD · Eu Ivd Self Testing ·ARKRAY Factory, Inc.·On the market

Lactate Pro 2 (LT-1730)

Device
EU IVDD · Eu Ivd Self Testing ·ARKRAY Factory, Inc.·On the market