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URIT-8280 Automatic Chemistry Analyzer
EUDAMEDClass A (EU MDR)
Ref /Model URIT-8460、CA-430A、CA-430B、CA-810A、CA-640A、CA-640B、URIT-8280、CA-810B、CA-810C
Identity
- Trade Name
- URIT-8280 Automatic Chemistry Analyzer EUDAMED
- Device Name
- Automatic Chemistry Analyzer EUDAMED
- Model / Reference
- URIT-8460、CA-430A、CA-430B、CA-810A、CA-640A、CA-640B、URIT-8280、CA-810B、CA-810C EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740732079 EUDAMED
- Basic UDI-DI
- 69357407ICA000001K3 EUDAMED
- Direct Marketing DI
- 06935740732079 EUDAMED
- EMDN Code
- W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
URIT-8280 Automatic Chemistry Analyzer by URIT Medical Electronic Co., Ltd. — Class A — 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 | 69357407ICA000001K3 | Class A | 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 f90a78a1-dc68-4448-b964-e8a170fd585f 61 fields · synced Jun 17, 2026