RapidFor™D-Dimer/cTnI/NT-proBNP Test Kit (FIA)
by Vitrosens Biotechnology Inc. EUDAMED
Active
Ref VMPO48
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08683548250865 | Date16 Jan 2024 | 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- Withdrawn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
- D-Dimer/cTnI/NT-proBNP Test Kit (FIA)
- Model / Reference
- VMPO48
- Primary DI / UDI-DI
- 08683548250865
- Basic UDI-DI
- B-08683548250865
- EMDN Code
- W0102060313,W0102160703,W0103020803
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- TR-MF-000026452
Other devices from Vitrosens Biotechnology Inc.
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Surgical Instrument: No