GAMA GROUP a.s.

Certificate 23 0517 QR/NB

Issued

Valid until: Nov 9, 2028

Certificate 23 0517 QR/NB is a valid Quality management system issued to GAMA GROUP a.s. and registered in EUDAMED. Valid until November 9, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 23 0517 QR/NB
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 102323 0517 QR/NB

Validity

Issued: Nov 10, 2023
Valid from: Nov 10, 2023
Valid until: Nov 9, 2028

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

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I5

5 scopes

Infusion sets for gravity feed, Double-ended piercing spike, Venous pressure meters, Flow regulator infusion
Class I
Infusion sets for gravity feed
Class I
Double-ended piercing spike
Class I
Venous pressure meters
Class I
Flow regulator infusion
Class I