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OKmeter Match Premium Blood Glucose Strip
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref OK1
Identity
- Trade Name
- OKmeter Match Premium Blood Glucose Strip EUDAMED
- Device Name
- OKmeter Match Premium Blood Glucose Test Strip EUDAMED
- Model / Reference
- OK1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712803566756 EUDAMED
- Basic UDI-DI
- B-04712803566756 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Cyprus 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
OKmeter Match Premium Blood Glucose Strip 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-04712803566756 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- OK biotech co., Ltd
- EUDAMED SRN
- TW-MF-000028031
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED acafc73b-9f48-479b-a3cc-555948646902 61 fields · synced Jun 20, 2026