Singclean®
by Hangzhou Singclean Medical Products Co., Ltd. EUDAMED
Active
Ref IL-6-02-10tModel 10 tests/box
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-IL-6-02-10tNW | Date29 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Interleukin-6 (IL-6) Test Kit (Fluorescence immunochromatography)
- Model / Reference
- 10 tests/box, IL-6-02-10t
- Primary DI / UDI-DI
- D-IL-6-02-10tNW
- Basic UDI-DI
- B-IL-6-02-10tNW
- EMDN Code
- W01030609 Interleukin 6 (il-6)
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014098
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No