IVDD Annex IV (excluding sections 4, 6) Expired

V1 027591 0045

Manufacturer: ARKRAY Factory, Inc.
Basic UDI-DIs
141
Scopes
0
Preceding Certs
0
Risk Classes
0
Characteristics
0
Revision
2
379
Expired 379 days ago
Expiry: May 26, 2025

Basic Information

Number
V1 027591 0045
Type
IVDD Annex IV (excluding sections 4, 6)
Expiry Date
May 26, 2025 Expired
Revision
2
Manufacturer
ARKRAY Factory, Inc.

Basic UDI-DIs

This Certificate is associated with 141 Basic UDI-DIs.

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-mini plus (GT-1960)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-mini plus (GT-1960)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W (GT-7210)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD SM TEST STRIPS

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S (GT-7110)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W (GT-7210)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W (GT-7210)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S (GT-7110)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD 01 SENSOR

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

Lactate Pro 2 (LT-1730)

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-mini plus (GT-1960)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W (GT-7210)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD G sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD SM TEST STRIPS

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD Σ Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S (GT-7110)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-meter CONTROL

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-mini plus (GT-1960)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S (GT-7110)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-meter CONTROL

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD SM (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-meter CONTROL

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W (GT-7210)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-mini plus (GT-1960)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD 01 CONTROL

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-meter (GT-1910)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-mini plus (GT-1960)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD G sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-meter (GT-1910)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S (GT-7110)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-mini plus (GT-1960)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD G sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S (GT-7110)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S (GT-7110)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD G sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD MX CONTROL

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD SM TEST STRIPS

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-mini plus (GT-1960)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-mini plus (GT-1960)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD 01 CONTROL

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD G sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD 01 SENSOR

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

Lactate Pro 2 (LT-1730)

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD Σ Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S (GT-7110)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD G sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD SM TEST STRIPS

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

Lactate Pro 2 Test Strip

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·ARKRAY Factory, Inc.·1 device

GLUCOCARD SM TEST STRIPS

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S (GT-7110)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD SM (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD SM TEST STRIPS

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

Lactate Pro 2 Test Strip

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD G sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-mini plus (GT-1960)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Control Solution

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S (GT-7110)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD MX CONTROL

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD 01 CONTROL

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD SM CONTROL

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD MX BLOOD GLUCOSE TEST STRIPS

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD Vital Test Strips 

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S onyx (GT-7120)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD SM CONTROL

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W (GT-7210)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD X-sensor

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S (GT-7110)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD W (GT-7210)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD S Test Strips

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device

GLUCOCARD Vital (GT-1050)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·ARKRAY Factory, Inc.·1 device