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URIT QC 22 Control Material for Urine Sediment Analyzer
EUDAMEDClass B (EU MDR)
Ref /Model URIT QC 22
Identity
- Trade Name
- URIT QC 22 Control Material for Urine Sediment Analyzer EUDAMED
- Device Name
- Control Material for Urine Sediment Analyzer EUDAMED
- Model / Reference
- URIT QC 22 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740713887 EUDAMED
- Basic UDI-DI
- 69357407IUSS0000112A EUDAMED
- EMDN Code
- W010106020601 URINE TESTING CONTROLS 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
URIT QC 22 Control Material for Urine Sediment Analyzer 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 | 69357407IUSS0000112A | 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 b4060f1a-bbff-4d4e-823d-9ed1900d06d1 61 fields · synced Jun 19, 2026