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Glucocard 01 Control
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 78547Ref 78546
Identity
- Trade Name
- GLUCOCARD 01 CONTROL EUDAMED
- Device Name
- GLUCOCARD 01 CONTROL EUDAMED
- Model / Reference
- 78547 EUDAMED78546 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-78547K6 EUDAMEDD-78546K4 EUDAMED
- Basic UDI-DI
- B-78547K6 EUDAMEDB-78546K4 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Glucocard 01 Control 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-78547K6 | 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 (2)
- EUDAMED 3927572e-9fc9-4a07-858b-bfd5124ca7db 61 fields · synced Jul 18, 2026
- EUDAMED b55b99f9-da58-49b2-b100-4e8ec4c9c129 61 fields · synced May 18, 2026