CHIRANA T.Injecta, a.s.

Certificate 2022-MDR/QS-024/B

Rev. 02Supplemented

Valid until: Sep 30, 2027

Certificate 2022-MDR/QS-024/B 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: 2022-MDR/QS-024/B
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652022-MDR/QS-024/B02

Validity

Issued: May 28, 2026
Valid from: May 28, 2026
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

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

History

Status changes

Supplemented

Supersedes

2022-MDR/QS-024/ASupplementedSep 11, 2023 → Sep 30, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class I11

11 scopes

INFUSION AND IRRIGATION SYRINGES, SINGLE-USE
Class I
ENTERAL FEEDING SYRINGES
Class I
ADMINISTRATION AND ASPIRATION FILTERS
Class I
SOLUTION FILTERS - OTHER
Class I
BLUNT NEEDLES
Class I
DEVICE
Class I
DEVICE
Class I
DEVICE
Class I
DEVICE
Class I
DEVICE
Class I
DEVICE
Class I

Documents

LanguagesENSK