Axtair Automorpho Plus
by Winncare France EUDAMED
Active
Ref VKAUTOP-120G2G-ESModel AXTAIR
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFR26/00000124 | Date14 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- FR26/00000124 Issued
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 14 Apr 2026
- Expires
- 14 Apr 2031
Specification
- Device Name
- Axtair
- Model / Reference
- AXTAIR, VKAUTOP-120G2G-ES
- Primary DI / UDI-DI
- 03664897033809
- Basic UDI-DI
- 366489700083H9
- EMDN Code
- V080701 Active anti-decubitus medical mattresses
- Device Class
- Class IIa
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- FR-MF-000000482
Other devices from Winncare France
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No