RapidFor™
by Vitrosens Biotechnology Inc. 279 variants
Ref VMD44Model VMD44BD, VMD44BDLA
Active
CE IVDR CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-08683347941506 | Date1 Sep 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-08683347941506 | Date1 Sep 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Device Name
- AFP Test Kit
- Model / Reference
- VMD44BD, VMD44, VMD44BDLA
- Primary DI / UDI-DI
- 08683347941506, 08684998273831
- Basic UDI-DI
- B-08683347941506, B-08684998273831, 868334794VMD44BD2L
- EMDN Code
- W0102039001 Alphafetoprotein
- Device Class
- Class IVD GeneralClass C
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000026452
Other devices from Vitrosens Biotechnology Inc.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No