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GLUCOCARD Σ Test Strips
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 70192Ref 70187
Identity
- Trade Name
- GLUCOCARD Σ Test Strips EUDAMED
- Device Name
- GLUCOCARD Σ Test Strips EUDAMED
- Model / Reference
- 70192 EUDAMED70187 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-70192GX EUDAMEDD-70187H6 EUDAMED
- Basic UDI-DI
- B-70192GX EUDAMEDB-70187H6 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Romania EUDAMEDGreece 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 Σ Test Strips 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-70192GX | 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 d7830285-ad7f-4c0e-a63b-bc2f91b8d346 61 fields · synced Sep 18, 2026
- EUDAMED c377930f-cead-464d-9b3d-ee99f2a524fd 61 fields · synced May 19, 2026