Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Motiva Implants

UDI-DI 07445161025999Basic UDI-DI 7445161Ergo2DiamondDH

Class III · MDR · Establishment Labs

Scan an inventory CSV

Identification

Model: Motiva Implants Ergonomix2 SmoothSilk
EMDN: P0601010201, X020102
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 768275

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-06-12 · Expiry 2028-01-05

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Establishment Labs

SRN CR-MF-000008155

CR · Alajuela

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

Motiva Implants 07445161026415
Motiva Implants 07445161017819
Motiva Implants 07445161026392
Motiva Implants 07445161025494
Motiva Implants 07445161026804
Motiva Implants 07445161026019
Motiva Implants 07445161026422
Motiva Implants 07445161026873
Motiva Implants 07445161025913
Motiva Implants 07445161017727
Motiva Implants 07445161017888
Motiva Implants 07445161025951

Showing 12 of 68 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/motiva-implants-5999 · UDI page: /udi/07445161025999

All devices from Establishment Labs

Scan an inventory CSV