Motiva Implants
by Establishment Labs EUDAMED
Active
Ref ERVF-145Model Motiva Implants Ergonomix Round VelvetSurface
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 798371 | Date12 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 32 countries, as listed in EUDAMED:
- Austria since 2 Jan 2025
- Belgium since 2 Jan 2025
- Bulgaria since 2 Jan 2025
- Croatia since 2 Jan 2025
- Cyprus since 2 Jan 2025
- Czechia since 2 Jan 2025
- Denmark since 2 Jan 2025
- Estonia since 2 Jan 2025
- Finland since 2 Jan 2025
- France since 2 Jan 2025
- Germany since 2 Jan 2025
- Greece since 2 Jan 2025
- Hungary since 2 Jan 2025
- Iceland since 2 Jan 2025
- Ireland since 2 Jan 2025
- Italy since 2 Jan 2025
- Latvia since 2 Jan 2025
- Liechtenstein since 2 Jan 2025
- Lithuania since 2 Jan 2025
- Luxembourg since 2 Jan 2025
- Malta since 2 Jan 2025
- Netherlands since 2 Jan 2025
- Northern Ireland since 2 Jan 2025
- Norway since 2 Jan 2025
- Poland since 2 Jan 2025
- Portugal since 2 Jan 2025
- Romania since 2 Jan 2025
- Slovakia since 2 Jan 2025
- Slovenia since 2 Jan 2025
- Spain since 2 Jan 2025
- Sweden since 2 Jan 2025
- Türkiye since 2 Jan 2025
Certificates
- MDR 798371 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 12 Jun 2026
- Expires
- 1 Jan 2030
- Reason
- Change approved
Specification
- Model / Reference
- Motiva Implants Ergonomix Round VelvetSurface, ERVF-145
- Primary DI / UDI-DI
- 07445161011510, 07445161011466
- Basic UDI-DI
- 7445161ErgoVelvetM5
- EMDN Code
- P0601010202,X020102
- Device Class
- Class III
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CR-MF-000008155
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Establishment Labs
Properties
Other properties (11)
- 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