RapidFor™ FOB Rapid Test Kit
by Vitrosens Biotechnology Inc. EUDAMED
Active
Ref VMD09, VMD09TD40
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-08683548254092 | Date4 Apr 2024 | StatusActive |
| European Union | CE/IVDD | NumberB-08683548254092 | Date4 Apr 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Trade Name
- RapidFor™ FOB Rapid Test KitRapidFor™
- Device Name
- FOB Rapid Test KitFOB Test Kit
- Model / Reference
- VMD09, VMD09TD40
- Primary DI / UDI-DI
- 08683548254092
- Basic UDI-DI
- B-08683548254092, 868354825VMD09TD2Y
- EMDN Code
- W0102160203 Fecal occult blood - rt & poc
- Device Class
- Class IVD GeneralClass C
- Market of Registration
- GermanyTürkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000026452
Other devices from Vitrosens Biotechnology Inc.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Surgical Instrument: No
- New Device: No