Motiva Flora
by Establishment Labs Costa Rica EUDAMED
Ref XML-58Model Motiva Flora Tissue Expander - Corsé Low Height 345 cc, Motiva Flora Tissue Expander
EMDN P060299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 768277 | Date12 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 768277 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 12 Jun 2026
- Expires
- 5 Jan 2028
- Reason
- Change approved
Specification
- Trade Name
- Motiva FloraMotiva Implants
- Model / Reference
- Motiva Flora Tissue Expander - Corsé Low Height 345 cc, XML-58, Motiva Flora Tissue Expander
- Primary DI / UDI-DI
- 07445161017666
- Basic UDI-DI
- B-07445161017666, 7445161TissueExpanNH
- EMDN Code
- P060299 Breast implants, expander - other
- Device Class
- Class III
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CR-MF-000008155
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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 (2)
- EUDAMED ad0defe3-12d6-43ef-a30a-288f05906dca
- EUDAMED 07445161017666|7445161TISSUEEXPANNH