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URIT FC 23 Focusing Fluid for Urine Sediment Analyzer
EUDAMEDClass A (EU MDR)
Ref /Model URIT FC 23
Identity
- Trade Name
- URIT FC 23 Focusing Fluid for Urine Sediment Analyzer EUDAMED
- Device Name
- Focusing Fluid for Urine Sediment Analyzer EUDAMED
- Model / Reference
- URIT FC 23 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740713924 EUDAMED
- Basic UDI-DI
- 69357407IUSS00000229 EUDAMED
- EMDN Code
- W010106020601 URINE TESTING CONTROLS EUDAMED
Classification
- Device Class
- Class A 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
URIT FC 23 Focusing Fluid for Urine Sediment Analyzer by URIT Medical Electronic Co., Ltd. — Class A — 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 | 69357407IUSS00000229 | Class A | 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 c5bf31a0-e7af-4677-9082-a0797e2947ca 61 fields · synced Jun 19, 2026