Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
- Manufacturer
- Establishment Labs
- Manufacturer SRN
- CR-MF-000008155
- UDI-DI
- 07445161008442
- Basic UDI-DI
- 7445161ErgoroundZen8Y
- Reference
- ERSD-575Z
- EMDN
- P0601010201
- EMDN description
- BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE
- First on market country
- -
- Safety summary (SSCP/SSP)
- SSCP-00100 · Rev. 8
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 13.07.2026 08:57