Motiva Implants
by Establishment Labs Costa Rica EUDAMED
Ref ERSD-265ZModel ERSM-105Z
EMDN P0601010201,X020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7445161ErgoroundZen8Y | Date25 Oct 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 745219 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 12 Jun 2026
- Expires
- 22 May 2027
- Reason
- Change approved
Specification
- Device Name
- Breast Implant Round - Mini with Qid Ergonomix 105 cc - S
- Model / Reference
- ERSM-105Z, ERSD-265Z
- Primary DI / UDI-DI
- 07445161008343
- Basic UDI-DI
- 7445161ErgoroundZen8Y
- EMDN Code
- P0601010201,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 & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 07445161008343|7445161ERGOROUNDZEN8Y