Airflex
Ref Airflex DuoModel Duo
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05060121761568 05060121761568 | Date14 Oct 2026 | 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- Withdrawn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/MDD Active
Specification
- Model / Reference
- Duo, Airflex Duo
- Primary DI / UDI-DI
- 05060121761568
- Basic UDI-DI
- B-05060121761568
- EMDN Code
- V080701 Active anti-decubitus medical mattresses
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- UK-MF-000049050
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Rober Limited
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No