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CHIRAHEM DEHP Free, 1500mm Luer-Lock, without air ventil

by CHIRANA T.Injecta, a.s.

Ref CHT515Model Transfusion set

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 Number858601504TRANSFSET13P8 Basic UDI-DI 08586015048227UDI-DIDate5 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2022-MDR/QS-027/A Expiring Supplemented Expires in 334 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  • Withdrawn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
Transfusion set for single use
Model / Reference
Transfusion set, CHT515
Primary DI / UDI-DI
08586015048227
Basic UDI-DI
858601504TRANSFSET13P8
Direct Marketing DI
08586015048227
EMDN Code
A03010102 Infusion controllers with filter (also transfusion controllers)
Device Class
Class IIa
EU market of registration
Hungary

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

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No