Class IIIMDR 2017/745On the marketAnnex XVI applicableImplantableSingle useSterile
- Manufacturer
- Establishment Labs
- Manufacturer SRN
- CR-MF-000008155
- UDI-DI
- 07445161022097
- Basic UDI-DI
- 7445161Ergo2ZenTempNR
- Reference
- E2SM-500T
- EMDN
- X020102
- EMDN description
- PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE TOTALLY INTRODUCED INTO THE HUMAN BODY THROUGH SURGICALLY INVASIVE MEANS FOR THE PURPOSE OF MODIFYING THE ANATOMY OF BODY PARTS WITH THE EXCEPTION OF TATTOOING PRODUCTS AND PIERCINGS – NON RESORBABLE
- First on market country
- -
- Safety summary (SSCP/SSP)
- SSCP-001003 · Rev. 2
- Authorised representative
- Emergo Europe B.V.
- Last updated
- 15.07.2026 20:08