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Urine Reagent Strips
EUDAMEDClass B (EU MDR)
Ref /Model URIT 11FA、URIT 12FA、URIT 14FA
Identity
- Device Name
- Urine Reagent Strips EUDAMED
- Model / Reference
- URIT 11FA、URIT 12FA、URIT 14FA EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740714143 EUDAMED
- Basic UDI-DI
- 69357407IUCS000010QM EUDAMED
- Unit of Use DI
- 86935740714149 EUDAMED
- EMDN Code
- W0101060204 URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL) EUDAMED
Classification
- Device Class
- Class 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Urine Reagent Strips by URIT Medical Electronic Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69357407IUCS000010QM | Class 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 851f6f0a-cfd6-44f4-a144-a5965e2f0f86 61 fields · synced May 23, 2026