Technoplastin His
by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Ref 5003030Model TECHNOPLASTIN HIS, Technoplastin HIS
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-09120036860094 09120036860094 | Date17 Jul 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-09120036860094 09120036860094 | Date17 Jul 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- Withdrawn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
- Model / Reference
- TECHNOPLASTIN HIS, 5003030
- Primary DI / UDI-DI
- 09120036860094
- Basic UDI-DI
- B-09120036860094, 912003686TC6T00000019N
- EMDN Code
- W0103020101 Prothrombin time ( quick test )
- Device Class
- Class IVD GeneralClass C
- 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