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URIT-600/ URIT-610 Coagulation Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref /Model URIT-600、URIT-610
Identity
- Trade Name
- URIT-600/ URIT-610 Coagulation Analyzer EUDAMED
- Device Name
- Coagulation Analyzer EUDAMED
- Model / Reference
- URIT-600、URIT-610 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-2-167 EUDAMED
- Basic UDI-DI
- B-2-167 EUDAMED
- EMDN Code
- W0202020101 SEMI-AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
URIT-600/ URIT-610 Coagulation Analyzer by URIT Medical Electronic Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-2-167 | Class IVD General | 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 f664baf4-ef4f-4050-8541-399bd728c5af 61 fields · synced Jul 27, 2026