IL-6 STAT (eCLIA)
by Shenzhen Lifotronic Technology Co., Ltd. EUDAMED
Active
Ref 0320510101, IL-6 STAT (eCLIA)Model 50T, 50T,2×50T,100T,2×100T
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-06975984064017 | Date24 Apr 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-06975984064017 | Date24 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Model / Reference
- 50T, 0320510101, 50T,2×50T,100T,2×100T, IL-6 STAT (eCLIA)
- Primary DI / UDI-DI
- 06975984064017
- Basic UDI-DI
- B-06975984064017, 69703416803205094JW
- EMDN Code
- W01030609 Interleukin 6 (il-6)
- Device Class
- Class IVD GeneralClass B
- Market of Registration
- NetherlandsGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000005654
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No