Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

5cm ACT Single - INTL

UDI-DI 00180668000533Basic UDI-DI 0180668000ACTWE

Class IIb · MDR · Uromedica, Incorporated

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Identification

Model: —
EMDN: P080199
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

5cm ACT Double - INTL 00180668000526
6cm ACT Double - INTL 00180668000540
6cm ACT Single - INTL 00180668000557
7cm ACT Double - INTL 00180668000564
7cm ACT Single - INTL 00180668000571
8cm ACT Double - INTL 00180668000588
8cm ACT Single - INTL 00180668000595
9cm ACT Double - INTL 00180668000601
9cm ACT Single - INTL 00180668000618

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/5cm-act-single-intl-0533 · UDI page: /udi/00180668000533

All devices from Uromedica, Incorporated

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