VITROS™ ECL Assay Cup
by Shenzhen Lifotronic Technology Co., Ltd. China EUDAMED
Ref QO679012Model 3000 T
EMDN W050301020202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69703416803205158JX | Date9 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Assay Cup
- Model / Reference
- 3000 T, QO679012
- Primary DI / UDI-DI
- 06978139073773
- Basic UDI-DI
- 69703416803205158JX
- EMDN Code
- W050301020202 Samples analyses, plastic microtubes without additives
- Device Class
- Class A
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000005654
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 06978139073773|69703416803205158JX