Motiva Flora
by Establishment Labs Costa Rica EUDAMED
Ref XML-54Model Motiva Flora Tissue Expander - Corsé Low Height 260 cc, Motiva Flora Tissue Expander EMDN P060299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-07445161017659 | Date10 Nov 2025 | StatusActive |
| European Union | CE/MDD | NumberB-07445161017659 | Date10 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD 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 260 cc, XML-54, Motiva Flora Tissue Expander
- Primary DI / UDI-DI
- 07445161017659
- Basic UDI-DI
- B-07445161017659, 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
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 (2)
- EUDAMED f1f8f813-1c38-4b32-a6a3-df27ea407f3e
- EUDAMED 07445161017659|7445161TISSUEEXPANNH