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Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Urodynamická souprava malá USM - 1845 mm M

UDI-DI 08593540514004Basic UDI-DI 85935406TF14URODYNAMIKAAD

Class IIa · MDR · GAMA GROUP a.s.

Identification
Model
—
EMDN
U0599
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

26 0129 QR/NB

EU quality management system · valid

Notified body: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 (1023)

Valid from 2026-04-30 · Expiry 2031-04-29

Scope not stated in certificate data.

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

Manufacturer

GAMA GROUP a.s.

SRN CZ-MF-000011894

CZ · České Budějovice

manufacturer

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Canonical device page: /device/urodynamicka-souprava-mala-usm-1845-mm-m-4004 · UDI page: /udi/08593540514004

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