Cytoactiv
by Cytoimmun Diagnostics GmbH EUDAMED
Active
Ref SCA1950Model SCA1950, SCA1900
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-SCA1950SN | Date15 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Cytoactiv HPV L1 Screening Kit
- Model / Reference
- SCA1950, SCA1900
- Primary DI / UDI-DI
- D-SCA1950SN
- Basic UDI-DI
- B-SCA1950SN
- EMDN Code
- W01029099 Immunochemistry reagents - other
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000036555
Other devices from Cytoimmun Diagnostics GmbH
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No