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CHIRALINE 1, 8x1800mm

by CHIRANA T.Injecta, a.s.

Ref CHL318180Model Extension line

Expiring European Union

CE MDR

Valid until

30 Sep 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number858601504EXTENLINE14JG Basic UDI-DI 08586015048685UDI-DIDate5 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2022-MDR/QS-027/A Expiring Supplemented Expires in 332 days

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    12 Dec 2024
    Expires
    30 Sep 2027
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Extension line for single use
Model / Reference
Extension line, CHL318180
Primary DI / UDI-DI
08586015048685
Basic UDI-DI
858601504EXTENLINE14JG
Direct Marketing DI
08586015048685
EMDN Code
A03020101 Low pressure extension lines
Device Class
Class IIa
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
SK-MF-000003702

Other devices from CHIRANA T.Injecta, a.s.

See all devices from CHIRANA T.Injecta, a.s. →

Properties

  • Sterile
  • CMR Substance
  • Endocrine Disruptor
  • Administering Medicine

Other properties (9)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No