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Calibrator Solution for Urine Analyzer
EUDAMEDClass B (EU MDR)
Ref USUC00001088Model URIT YC 2ST
Identity
- Trade Name
- Calibrator Solution for Urine Analyzer EUDAMED
- Device Name
- Calibrator Solution for Urine Analyzer EUDAMED
- Model / Reference
- URIT YC 2ST EUDAMEDUSUC00001088 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740750226 EUDAMED
- Basic UDI-DI
- 69357407IUCS000006QW EUDAMED
- EMDN Code
- W010106020602 URINE TESTING CALIBRATORS AND STANDARDS 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
Calibrator 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 | 69357407IUCS000006QW | 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 518ec5e7-df0d-4ca9-8f10-327d17494d62 61 fields · synced Jun 19, 2026