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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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CHIRANA T.Injecta, a.s.

Certificate 2022-MDR/QS-026

Rev. 00Issued
Valid until
Sep 30, 2027

Overview

Certificate number
2022-MDR/QS-026
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-02600

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 IIa11

11 scopes

  • Non-active and Non-implantable Medical Devices: Sterile Syringes for Single Use
    Class IIa
  • Sterile Hypodermic Syringe for Single use, Trade Name: CHIRANA
    Class IIa
  • Sterile Hypodermic Syringe for Single use, Trade Name: ECOJECT
    Class IIa
  • Sterile Injection Set for Single Use, Trade Name: CHIRANA
    Class IIa
  • Sterile Injection Set for Single Use, Trade Name: SYRISET
    Class IIa
  • Sterile Insulin Syringe with / without Integrated Needle or Side Packed Needle for Single Use, Trade Name: CHIRANA
    Class IIa
  • Sterile Tubercilin Syringe with / without Integrated Needle or Side Packed Needle for Single Use, Trade Name: CHIRANA
    Class IIa
  • Sterile Insulin Syringe with / without Integrated Needle or Side Packed Needle for Single Use, Trade Name: HARMOFINE
    Class IIa
  • Sterile Tuberculin Syringe with / without Integrated Needle or Side Packed Needle for Single Use, Trade Name: ACTI-FINE
    Class IIa
  • Sterile Perfusion Syringe for Single Use, Trade Name: CHIRANA
    Class IIa
  • Sterile Perfusion Syringe for Single Use, Trade Name: INFUJECT/ PERFUJECT
    Class IIa

Documents

LanguagesSKEN

Manufacturer

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