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GLUCOCARD X-meter CONTROL
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 78480Ref 78481Ref 78482
Identity
- Trade Name
- GLUCOCARD X-meter CONTROL EUDAMED
- Device Name
- GLUCOCARD X-meter CONTROL EUDAMED
- Model / Reference
- 78480 EUDAMED78481 EUDAMED78482 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-78480JX EUDAMEDD-78481JZ EUDAMEDD-78482K3 EUDAMED
- Basic UDI-DI
- B-78480JX EUDAMEDB-78481JZ EUDAMEDB-78482K3 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Czechia 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 X-meter 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-78480JX | 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 (3)
- EUDAMED 91049075-bed1-4ca3-8cb7-3a6995510f6a 61 fields · synced Jul 28, 2026
- EUDAMED 59e7c654-9ed7-45ec-bf0b-a5c9ed780ea2 61 fields · synced May 17, 2026
- EUDAMED c3da83eb-ab64-4022-82f8-1a9b906d040d 61 fields · synced May 19, 2026