Vois-Xs
by APrevent Biotech GmbH Austria EUDAMED
Ref APV001 EMDN P0204
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number912011786UVAHN | Date27 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 1000305807 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0297
- Issued
- 30 Mar 2026
- Expires
- 29 Mar 2031
- 1000305808 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 30 Mar 2026
- Expires
- 26 Mar 2030
- Reason
- Add device or group
Specification
- Device Name
- VOIS Implants
- Model / Reference
- APV001
- Primary DI / UDI-DI
- 09120117860012
- Basic UDI-DI
- 912011786UVAHN
- EMDN Code
- P0204 Larynx prostheses
- Device Class
- Class IIb
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- AT-MF-000001435
Other devices from APrevent Biotech GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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
Sources (1)
- EUDAMED 09120117860012|912011786UVAHN