Fully Automatic ELISA Analyzer
by Changsha Imadek Intelligent Technology Co., Ltd. China EUDAMED
Ref ME-8800LModel ME-1000 ME-2000、ME-2000Plus、ME-2000Pro、ME-4000、ME-4000Plus、ME-4000Pro ME-4800、ME-4800Plus、ME-4800Pro、ME-8000、ME-8000Plus、ME-8000Pro 、ME-8400、ME-8400Plus、ME-8400Pro ME-8800M、ME-8800S、ME-8800
EMDN W02010299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697431271MEYU | Date15 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- ME-1000 ME-2000、ME-2000Plus、ME-2000Pro、ME-4000、ME-4000Plus、ME-4000Pro ME-4800、ME-4800Plus、ME-4800Pro、ME-8000、ME-8000Plus、ME-8000Pro 、ME-8400、ME-8400Plus、ME-8400Pro ME-8800M、ME-8800S、ME-8800, ME-8800L
- Primary DI / UDI-DI
- 06974312710220
- Basic UDI-DI
- 697431271MEYU
- Direct Marketing DI
- 06974312710220
- EMDN Code
- W02010299 Immunochemistry instruments - other
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000042852
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Changsha Imadek Intelligent Technology Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 9e6d2479-de9d-4a73-a7c3-b6425f139534