Identity
- Trade Name
- Automatic Chemistry Analyzer EUDAMED
- Device Name
- Automatic Chemistry Analyzer EUDAMED
- Model / Reference
- CA2000 EUDAMEDQD0401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970522646960 EUDAMED
- Basic UDI-DI
- 697052264YQ09KX EUDAMED
- EMDN Code
- W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Automatic Chemistry Analyzer by Sichuan Orienter Biotechnology 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 | 697052264YQ09KX | Class A | Active |
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Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 73995f62-7793-40ce-b872-c714ae85746c 61 fields · synced Aug 3, 2026