EU Manufacturer
๐ฏ๐ต Japan
Active
ARKRAY Factory, Inc.
SRN: JP-MF-000003008
ยท
Koji 1480, 520-3306 Konan-cho, Koka-shi, Shiga, Japan
Basic UDI-DIs
410
Total Devices
430
On Market
430
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
31
Basic Information
- Address
- Koji 1480, 520-3306 Konan-cho, Koka-shi, Shiga, Japan
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
373
Eu Ivdr
37
Classification
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Eu Ivd General
232
Eu Ivd Annex 2 List B
137
Eu Ivd Class A
37
Eu Ivd Self Testing
4
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 027591 0045 | TรV SรD Product Service GmbH | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 31 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| A1C HD CONTROL | EU IVDD | Eu Ivd General | On Market | 0 |
| ADAMS A1C CONTROL | EU IVDD | Eu Ivd General | On Market | 0 |
| ADAMS A1c (HA-8180) | EU IVDD | Eu Ivd General | On Market | 0 |
| ADAMS A1c (HA-8180T) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| ADAMS A1c (HA-8180T) | EU IVDD | Eu Ivd General | On Market | 0 |
| ADAMS A1c (HA-8180T) | EU IVDD | Eu Ivd General | On Market | 0 |
| ADAMS A1c (HA-8180V) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| ADAMS A1c (HA-8180V) | EU IVDD | Eu Ivd General | On Market | 0 |
| ADAMS A1c (HA-8180V) | EU IVDD | Eu Ivd General | On Market | 0 |
| ADAMS A1c (HA-8190V) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| ADAMS A1c (HA-8190V) | EU IVDD | Eu Ivd General | On Market | 0 |
| ADAMS A1c (HA-8380V) | EU IVDD | Eu Ivd General | On Market | 0 |
| ADAMS A1c Lite (HA-8380V) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AMMONIA TEST KIT II | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION CHECK Plus | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION Control Solution | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION Diluent (BAC) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION Diluent (SED) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION ELEVEN (AE-4020) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTION ELEVEN (AE-4020) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTION ELEVEN (AE-4020) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTION ELEVEN (AE-4020) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION ELEVEN (AE-4020) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION ELEVEN (AE-4020) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION EYE (AI-4510) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION EYE Calibrator | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION EYE Control Solution | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION EYE Sheath Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTION EYE Sheath Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTION EYE Sheath Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTION EYE Sheath Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTION EYE Sheath Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTION EYE Sheath Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTION EYE Sheath Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTION EYE Sheath Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTION EYE Sheath Solution | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION MAX (AX-4030) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION MAX (AX-4030) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION MAX (AX-4030) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION MAX (AX-4060) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION MAX (AX-4060) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION MAX (AX-4060) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION SCREEN Microalbumin/Creatinine | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION Sheath Solution | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION Staining Solution (BAC) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION Staining Solution (SED) | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION Sticks 10EA | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION Sticks 10EA | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION Sticks 10EA | EU IVDD | Eu Ivd General | On Market | 0 |
| AUTION Sticks 10PA | EU IVDD | Eu Ivd General | On Market | 0 |