ZENIT RA D-SORB Solution
Ref 41436
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number805432095DSORBAU 08054320950783 | Date25 Oct 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Tgs Ta D-Sorb
- Model / Reference
- 41436
- Primary DI / UDI-DI
- 08054320950783
- Basic UDI-DI
- 805432095DSORBAU
- Direct Marketing DI
- 08054320950783
- EMDN Code
- W01029099 Immunochemistry reagents - other
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000025331
Other devices from Technogenetics S.p.A
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