Singclean®
by Hangzhou Singclean Medical Products Co., Ltd. China EUDAMED
Ref IVD49-02-20tModel Cassette
EMDN W0105041101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06936020115193 | Date17 Dec 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Certificates
- IVDR 823886 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 2797
- Issued
- 17 Aug 2026
- Expires
- 16 Aug 2031
Specification
- Device Name
- COVID-19 Test kit (Colloidal Gold Method)SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Method)
- Model / Reference
- IVD49-02-20t, Cassette
- Primary DI / UDI-DI
- 06936020115193, 06936020111706, 06936020116411, 06936020115100, 06936020141550
- Basic UDI-DI
- B-06936020115193, B-06936020111706, B-06936020116411, B-06936020115100, 69360201188X
- EMDN Code
- W0105041101, W0105099099
- Device Class
- Class IVD devices for self-testingClass IVD GeneralClass C
- Market of Registration
- GermanyCroatia
Manufacturer details
- EUDAMED SRN
- CN-MF-000014098
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hangzhou Singclean Medical Products Co., Ltd.
See all devices from Hangzhou Singclean Medical Products Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Human Tissues: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (5)
- EUDAMED 0d005ed4-838d-43e0-81c2-2ec93b8a46b3
- EUDAMED 06936020111706|B-06936020111706
- EUDAMED 06936020116411|B-06936020116411
- EUDAMED 06936020115100|B-06936020115100
- EUDAMED 06936020141550|69360201188X