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Blood Glucose Meter
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref /Model URIT-25,URIT-26,URIT-28,URIT-82,URIT-86
Identity
- Device Name
- Blood Glucose Meter EUDAMED
- Model / Reference
- URIT-25,URIT-26,URIT-28,URIT-82,URIT-86 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-4-26K EUDAMED
- Basic UDI-DI
- B-4-26K EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS 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
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Blood Glucose Meter 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-4-26K | 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 61b0a8a7-73b5-4ac6-abe1-f5ef31ea4251 61 fields · synced Oct 8, 2026