CHIRANA T.Injecta, a.s.

Certificate 2022-MDR/QS-027

Rev. 00Issued

Valid until: Sep 30, 2027

Certificate 2022-MDR/QS-027 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-027
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652022-MDR/QS-02700

Validity

Issued: Sep 30, 2022
Valid from: Sep 30, 2022
Valid until: Sep 30, 2027

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

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: Yes
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 IIa12

12 scopes

Non-active and Non-implantable Medical Devices: Tubular Devices
Class IIa
Non-active and Non-implantable Medical Devices: Adapters, Connectors, Ramps, Stopcock, Caps
Class IIa
Non-active and Non-implantable Medical Devices: Arterio-Venous System Devices
Class IIa
Infusion Set for Single Use, Trade Name: CHIRAPLUS G
Class IIa
Infusion Set for Single Use, Trade Name: CHIRAPLUS P
Class IIa
Transfusion Set for Single Use, Trade Name: CHIRAHEM
Class IIa
Extension Line for Single Use, Trade Name: CHIRALINE
Class IIa
Mandrin for Single Use, Trade Name: CHIRAFLEX
Class IIa
Three Way Stop Cock for Single Use, Trade Name: CHIRAWAY
Class IIa
Stopper for Single Use, Trade Name: CHIRAPLUS
Class IIa
Port for Single Use, Trade Name: CHIRAPLUS
Class IIa
I.V. Cannula for Single Use, Trade Name: CHIRAFLEX / CHIRAFLEX SAFETY
Class IIa

Scope coverage

Class IIa12

12 scopes

Non-active and Non-implantable Medical Devices: Tubular Devices
Class IIa
Non-active and Non-implantable Medical Devices: Adapters, Connectors, Ramps, Stopcock, Caps
Class IIa
Non-active and Non-implantable Medical Devices: Arterio-Venous System Devices
Class IIa
Infusion Set for Single Use, Trade Name: CHIRAPLUS G
Class IIa
Infusion Set for Single Use, Trade Name: CHIRAPLUS P
Class IIa
Transfusion Set for Single Use, Trade Name: CHIRAHEM
Class IIa
Extension Line for Single Use, Trade Name: CHIRALINE
Class IIa
Mandrin for Single Use, Trade Name: CHIRAFLEX
Class IIa
Three Way Stop Cock for Single Use, Trade Name: CHIRAWAY
Class IIa
Stopper for Single Use, Trade Name: CHIRAPLUS
Class IIa
Port for Single Use, Trade Name: CHIRAPLUS
Class IIa
I.V. Cannula for Single Use, Trade Name: CHIRAFLEX / CHIRAFLEX SAFETY
Class IIa

Certificate 2022-MDR/QS-027

Overview

Validity

Notified body

Covered devices

Characteristics

History

Scope coverage

Certificate 2022-MDR/QS-027

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Manufacturer

Documents