Pro-care Auto
Ref 9P-087520Model Pro-care Auto
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-04719893312843 | Date10 Jun 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- 9P-087520
- Model / Reference
- 9P-087520, Pro-care Auto
- Primary DI / UDI-DI
- 04719893312843, 04719893350661, 04719893349696, 04719893354072, 04719893356076, 04719893352245, 04719893349542, 04719893350197, 04719893349665, 04719893353648, 04719893356298
- Basic UDI-DI
- B-04719893312843, B-04719893350661, B-04719893349696, B-04719893354072, B-04719893356076, B-04719893352245, B-04719893349542, B-04719893350197, B-04719893349665, B-04719893353648, B-04719893356298
- EMDN Code
- V080701 Active anti-decubitus medical mattresses
- Device Class
- Class IIa
- EU market of registration
- SpainDenmarkFranceNetherlands
Manufacturer details
- EUDAMED SRN
- TW-MF-000009159
- Authorised representative
- Wellell Iberia S.L. ES-AR-000003668
Other devices from Wellell Inc.
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