Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Infuzní souprava IS-123 M

UDI-DI 08593540513328Basic UDI-DI 85935406TF03ISPRETLAKKM

Class IIa · MDR · GAMA GROUP a.s.

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Identification

Model: —
EMDN: A03040199
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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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/infuzni-souprava-is-123-m-3328 · UDI page: /udi/08593540513328

All devices from GAMA GROUP a.s.

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