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GLUCOCARD S onyx (GT-7120)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 109323Ref 104166Ref 109315Ref 109322Ref 109321Ref 109050Ref 105294
Identity
- Trade Name
- GLUCOCARD S onyx (GT-7120) EUDAMED
- Device Name
- GLUCOCARD S onyx (GT-7120) EUDAMED
- Model / Reference
- 109323 EUDAMED104166 EUDAMED109315 EUDAMED109322 EUDAMED109321 EUDAMED109050 EUDAMED105294 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-109323MW EUDAMEDD-104166M3 EUDAMEDD-109315MX EUDAMEDD-109322MU EUDAMEDD-109321MS EUDAMEDD-109050MJ EUDAMEDD-105294ML EUDAMED
- Basic UDI-DI
- B-109323MW EUDAMEDB-104166M3 EUDAMEDB-109315MX EUDAMEDB-109322MU EUDAMEDB-109321MS EUDAMEDB-109050MJ EUDAMEDB-105294ML EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMEDW0101060101,W0201060102 EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Ireland EUDAMEDCzechia EUDAMEDCroatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
GLUCOCARD S onyx (GT-7120) by ARKRAY Factory, Inc. — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-109323MW | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (7)
- EUDAMED 3b138e14-0a24-476c-bb56-9f7f2b3f579e 61 fields · synced Jul 27, 2026
- EUDAMED 486ab325-a43c-4443-921f-d4e5cd2a89c2 61 fields · synced May 16, 2026
- EUDAMED adce30c4-c089-4e91-aeaf-bb5cbfc3065c 61 fields · synced May 16, 2026
- EUDAMED aaebc8ab-f018-417f-9e36-d43da3ae5695 61 fields · synced May 16, 2026
- EUDAMED ab775424-2f5b-45e6-abcf-fe987bc395da 61 fields · synced May 17, 2026
- EUDAMED 01bd1b67-5d5b-4469-8775-c84bca83a475 61 fields · synced May 18, 2026
- EUDAMED 5ff2eef5-25e9-40bd-b8d9-f8e03eb1dd9c 61 fields · synced May 18, 2026