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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

12cm ProACT Double - INTL

UDI-DI 00180668000489Basic UDI-DI 0180668000PROZU

Class IIb · MDR · Uromedica, Incorporated

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

G70 045789 0021

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-08-03 · Expiry 2031-08-02

Scope not stated in certificate data.

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

Manufacturer

Uromedica, Incorporated

SRN US-MF-000008932

US · Plymouth

manufacturer

Authorised representative: MediMark Europe Sarl. (FR-AR-000000182)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/12cm-proact-double-intl-0489 · UDI page: /udi/00180668000489

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