GAMA GROUP a.s.

Certificate 26 0129 QR/NB

Issued

Valid until: Apr 29, 2031

Certificate 26 0129 QR/NB is a valid Quality management system issued to GAMA GROUP a.s. and registered in EUDAMED. Valid until April 29, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 26 0129 QR/NB
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 102326 0129 QR/NB

Validity

Issued: Apr 30, 2026
Valid from: Apr 30, 2026
Valid until: Apr 29, 2031

Notified body

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

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa19

19 scopes

Suction catheters, Catheters for neonates, Rectal catheters, GAMAPLUS, Transfer sets, Nasal oxygen introduction catheter, Priming set of dialysis sets, Infusion sets for overpressure infusion, Transfusion sets, Small urodynamic sets, Needleless port, Stopcocks, SKALA OK 3 Perfusion set, Safety valve
Class IIa
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