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Quality Control Solution for Urine Analyzer
EUDAMEDClass B (EU MDR)
Ref USUC00001084Model URIT YQ 3STCRef USUC00001102Ref /Model UNAMAX U11 Control，UNAMAX U14 ControlRef USUD00000286Model UQC-4SG
Identity
- Trade Name
- Quality Control Solution for Urine Analyzer EUDAMED
- Device Name
- Quality Control Solution for Urine Analyzer EUDAMED
- Model / Reference
- URIT YQ 3STC EUDAMEDUSUC00001084 EUDAMEDUSUC00001102 EUDAMEDUNAMAX U11 Control，UNAMAX U14 Control EUDAMED/ EUDAMEDUQC-4SG EUDAMEDUSUD00000286 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740750189 EUDAMED06935740750172 EUDAMEDD-1-468 EUDAMED06935740751742 EUDAMED
- Basic UDI-DI
- 69357407IUCS000005QU EUDAMEDB-1-468 EUDAMED69357407IUCS000008R2 EUDAMED
- EMDN Code
- W010106020601 URINE TESTING CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDItaly 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 — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69357407IUCS000005QU | Class B | Active |
| 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 (4)
- EUDAMED 617f11f6-8c44-4ba1-995f-39c2ae532a08 61 fields · synced Oct 6, 2026
- EUDAMED c3025af6-7985-4a1c-9c75-51e2312183b2 61 fields · synced May 17, 2026
- EUDAMED d345e3fe-7a12-48f2-a0e6-c90b7979a9c3 61 fields · synced Aug 3, 2026
- EUDAMED d3e8fc8c-e539-47ad-8df2-1cce254cf9dd 61 fields · synced Sep 17, 2026