Technofluor FXIII:Act
by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Ref 5800200
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/IVDD | Number912003686TCFB00000019R 09120036864023 | Date11 Aug 2026 | StatusActive |
| European Union | CE/IVDR | Number912003686TCFB00000019R 09120036864023 | Date11 Aug 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Specification
- Device Name
- TECHNOFLUOR FXIII Activity
- Model / Reference
- 5800200
- Primary DI / UDI-DI
- 09120036864023
- Basic UDI-DI
- 912003686TCFB00000019R, B-09120036864023
- EMDN Code
- W0103020213 Coagulation factor XIII
- Device Class
- Class CClass IVD General
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- AT-MF-000024115
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No