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Quality Control Solution for Urine Analyzer
EUDAMEDClass B (EU MDR)
Ref USUC00001085Model URIT YQ 3STC
Identity
- Trade Name
- Quality Control Solution for Urine Analyzer EUDAMED
- Device Name
- Quality Control Solution for Urine Analyzer EUDAMED
- Model / Reference
- URIT YQ 3STC EUDAMEDUSUC00001085 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740750196 EUDAMED
- Basic UDI-DI
- 69357407IUCS000005QU 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
Quality Control Solution for Urine 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 | 69357407IUCS000005QU | 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 2272be76-db3a-4555-8067-dbe2b46433aa 61 fields · synced Oct 5, 2026