← Back to catalogue
VOX Blood Glucose Test Strips
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref OK3I
Identity
- Trade Name
- VOX Blood Glucose Test Strips EUDAMED
- Device Name
- VOX Blood Glucose Test Strips EUDAMED
- Model / Reference
- OK3I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760164730249 EUDAMED
- Basic UDI-DI
- B-03760164730249 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
VOX Blood Glucose Test Strips by Ok Biotech Co., Ltd. — 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-03760164730249 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OK biotech co., Ltd
- EUDAMED SRN
- TW-MF-000028031
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 2b65a3ee-9c94-4330-b0a7-ac87cef7055d 61 fields · synced Jun 18, 2026