← Back to catalogue
GLUCOCARD G sensor
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 34847Ref 77741Ref 38995
Identity
- Trade Name
- GLUCOCARD G sensor EUDAMED
- Device Name
- GLUCOCARD G sensor EUDAMED
- Model / Reference
- 34847 EUDAMED77741 EUDAMED38995 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-34847HD EUDAMEDD-77741JV EUDAMEDD-38995JR EUDAMED
- Basic UDI-DI
- B-34847HD EUDAMEDB-77741JV EUDAMEDB-38995JR EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS 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
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
GLUCOCARD G sensor 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-34847HD | 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 (3)
- EUDAMED 6de06714-f17b-40f9-9402-b9b5bebf9701 61 fields · synced Jul 17, 2026
- EUDAMED 23bb226f-5eb1-4961-9402-c75b2a1dd140 61 fields · synced May 16, 2026
- EUDAMED 8c58db63-6130-4172-8e00-f9d7aa76844f 61 fields · synced May 18, 2026