Motiva Implants
by Establishment Labs Costa Rica EUDAMED
Ref SZF-275ZModel Motiva Implants Round Sizers with Zen EMDN P0699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7445161RoundsizersZenDE | Date5 Nov 2025 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Withdrawn
Specification
- Model / Reference
- Motiva Implants Round Sizers with Zen, SZF-275Z
- Primary DI / UDI-DI
- 07445161019660
- Basic UDI-DI
- 7445161RoundsizersZenDE
- EMDN Code
- P0699 Breast implants - other
- Device Class
- Class IIa
Manufacturer details
- EUDAMED SRN
- CR-MF-000008155
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Establishment Labs
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
Sources (1)
- EUDAMED 349f0b81-e987-445a-8f88-670bf6e5f2ce