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CI 2000S Automated Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref 69543760Y00001DJModel CI 2000S
Identity
- Trade Name
- CI 2000S Automated Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- CI 2000S Automated Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- CI 2000S EUDAMED69543760Y00001DJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954376005173 EUDAMED
- Basic UDI-DI
- 69543760Y00002DL EUDAMED
- Direct Marketing DI
- 06954376005173 EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) 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
Yes
EUDAMED
CI 2000S Automated Chemiluminescence Immunoassay Analyzer by Beijing Leadman Biochemistry Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 69543760Y00002DL | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing Leadman Biochemistry Co., Ltd.
- EUDAMED SRN
- CN-MF-000020150
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2699596a-7155-42a8-9d14-2e341109edeb 61 fields · synced Jun 19, 2026