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CS-2000i
EUDAMEDClass A (EU MDR)
Ref 3012225Model CS-2000 CS-2000i Ref CS-2000i
Identity
- Trade Name
- CS-2000i EUDAMEDAuto-Chemistry Analyzer EUDAMED
- Device Name
- Auto-Chemistry Analyzer EUDAMED
- Model / Reference
- CS-2000 CS-2000i EUDAMED3012225 EUDAMEDCS-2000i EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794520012 EUDAMED
- Basic UDI-DI
- 69257945W0201010104D0JW EUDAMEDB-06925794520012 EUDAMED
- EMDN Code
- W0201010104 CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h > 1.200) EUDAMEDW0201010108 CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200) EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
CS-2000i by Dirui Industrial Co., Ltd — Class A — 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 | 69257945W0201010104D0JW | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 69257945W0201010104D0JW | Class A | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 2bf57dec-15eb-49e6-996e-7954fcfe829b 61 fields · synced Jun 18, 2026
- EUDAMED 39d3a2ee-1af0-4e9d-971c-b8a43839cf88 61 fields · synced Jun 11, 2026