Motiva Implants
by Establishment Labs 1,000+ variants
Ref DSC-290TModel Motiva Implants Ergonomix2 SmoothSilk with ZenT
Active
CE MDR
Valid until
5 Jan 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 768275 | Date12 Jun 2026 | StatusActive |
Certificates
- MDR 768275 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 12 Jun 2026
- Expires
- 5 Jan 2028
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Motiva Implants Ergonomix2 SmoothSilk with ZenT, DSC-290T
- Primary DI / UDI-DI
- 07445161022936
- Basic UDI-DI
- 7445161Ergo2DiamZenTempZS
- EMDN Code
- P0601010202, X020102
- Device Class
- Class III
- EU 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