← Back to catalogue
GLUCOCARD X-meter (GT-1910)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 47536
Identity
- Trade Name
- GLUCOCARD X-meter (GT-1910) EUDAMED
- Device Name
- GLUCOCARD X-meter (GT-1910) EUDAMED
- Model / Reference
- 47536 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47536HR EUDAMED
- Basic UDI-DI
- B-47536HR EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
GLUCOCARD X-meter (GT-1910) 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-47536HR | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (1)
- EUDAMED 2828dbdf-ee2d-4a27-b08c-acc919312124 61 fields · synced Jul 12, 2026