CHIRANA T.Injecta, a.s.

Certificate 2024-MDR/QS-071

Rev. 00Issued

Valid until: Sep 30, 2027

Certificate 2024-MDR/QS-071 is a valid Quality management system issued to CHIRANA T.Injecta, a.s. and registered in EUDAMED. Valid until September 30, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 2024-MDR/QS-071
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652024-MDR/QS-07100

Validity

Issued: Dec 12, 2024
Valid from: Dec 12, 2024
Valid until: Sep 30, 2027

Manufacturer

Manufacturer: CHIRANA T.Injecta, a.s.
Manufacturer SRN: SK-MF-000003702
Manufacturer country: Slovakia

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

Infusion set for single useClass IIb
858601504INFUSIONSET12XF

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: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

INFUSION CONTROLLERS
Class IIb
DEVICE
Class IIb

Documents

LanguagesENSK