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Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

SKALA OK3-V3 Lavážní set M

UDI-DI 08593540514097Basic UDI-DI 85935406TF29SETPROLAVAZEX

Class IIa · MDR · GAMA GROUP a.s.

Identification
Model
—
EMDN
V80
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

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/skala-ok3-v3-lavazni-set-m-4097 · UDI page: /udi/08593540514097

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