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Blood Glucose Test Strip
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref /Model URIT G25,URIT G26,URIT G28,URIT G28 No coding,URIT G80 No coding
Identity
- Device Name
- Blood Glucose Test Strip EUDAMED
- Model / Reference
- URIT G25,URIT G26,URIT G28,URIT G28 No coding,URIT G80 No coding EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-4-16H EUDAMED
- Basic UDI-DI
- B-4-16H EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany 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
Blood Glucose Test Strip by URIT Medical Electronic 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-4-16H | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 032d9791-4b6b-41a5-975b-0a47effdaaa0 61 fields · synced Jul 24, 2026