Evo Autoimmune SPA
Ref 3AU3020 TPOModel Evo Autoimmune SPA
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 | Number8058945153AU3020AIHM 48058945154678 | Date24 Sep 2023 | 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- Withdrawn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
- Autoimmunity SPA - Autoimmunità SPA
- Model / Reference
- Evo Autoimmune SPA, 3AU3020 TPO
- Primary DI / UDI-DI
- 48058945154678
- Basic UDI-DI
- 8058945153AU3020AIHM
- Direct Marketing DI
- 48058945154678
- EMDN Code
- W0102109099 Auto-immune disease tests - other
- Device Class
- Class A
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000029729
Other devices from Abd SRL
Properties
Other properties (8)
- Sterile: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No