Unknown / Not in EUDAMED

Snapshot 2026-10-17 · Link to EUDAMED

Motiva Implants

UDI-DI 07445161018618Basic UDI-DI 7445161ErgoVelvetZenPE

Class III · MDR · Establishment Labs

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Identification

Model: Motiva Implants Ergonomix VelvetSurface with Zen
EMDN: P0601010202, X020102
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 798371

EU technical documentation assessment · unknown

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

Valid from 2026-06-12 · Expiry 2030-01-01

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)

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Showing 12 of 79 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/motiva-implants-8618 · UDI page: /udi/07445161018618

All devices from Establishment Labs

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