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Glucocard Sm (gt-7120)
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 47396Ref 102023
Identity
- Trade Name
- GLUCOCARD SM (GT-7120) EUDAMED
- Device Name
- GLUCOCARD SM (GT-7120) EUDAMED
- Model / Reference
- 47396 EUDAMED102023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47396HZ EUDAMEDD-102023KW EUDAMED
- Basic UDI-DI
- B-47396HZ EUDAMEDB-102023KW EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Italy 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 Sm (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-47396HZ | 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 0b7f25be-96d7-4d73-af91-5f1ef40d79a7 61 fields · synced Aug 1, 2026
- EUDAMED 9d1da7ac-e7ed-4f7b-b49d-de38407f74ba 61 fields · synced May 19, 2026