Acella, 20µm, 1-chamber
Ref Acella 20
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 | Number8720618711OEMC9 08720618711229 | Date16 May 2024 | 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- Withdrawn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
- Analysis Slides
- Model / Reference
- Acella 20
- Primary DI / UDI-DI
- 08720618711229
- Basic UDI-DI
- 8720618711OEMC9
- Direct Marketing DI
- 08720618711229
- EMDN Code
- W05039099 Devices for samples analyses - other
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- NL-MF-000020626
Other devices from Attain Technologies B.V.
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- New Device: No