CHIRANA T.Injecta, a.s.

Certificate 2022-MDR/QS-025/D

Rev. 04Supplemented

Valid until: Sep 30, 2027

Certificate 2022-MDR/QS-025/D 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-025/D
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 22652022-MDR/QS-025/D04

Validity

Issued: Jul 13, 2026
Valid from: Jul 13, 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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

2022-MDR/QS-025/CQuality management systemSupplementedApr 22, 2026 → Sep 30, 2027

Scope coverage

Class IIa12

12 scopes

Sterile Hypodermic Needle for Single Use
Class IIa
Sterile Ophthalmic Needle for Single Use
Class IIa
Blood Collection Needle for Single Use
Class IIa
Insulin Pen Needle for Single Use
Class IIa
Scalp Vein Set for Single Use
Class IIa
Sterile Safety Hypodermic Needle for Single Use
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa

Documents

LanguagesENSK