Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Motiva Implants

UDI-DI 07445161017635Basic UDI-DI 7445161TissueExpanNH

Class III · MDR · Establishment Labs

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Identification

Model: Motiva Flora Tissue Expander
EMDN: P060299
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 768277

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)

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Motiva Implants 07445161017581
Motiva Implants 07445161017642
Motiva Implants 07445161017543
Motiva Implants 07445161017659
Motiva Implants 07445161017567

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/motiva-flora-7635 · UDI page: /udi/07445161017635

All devices from Establishment Labs

Scan an inventory CSV