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CHIRAPLUS P 190 SAFETY 1900mm Luer-Lock with safety roller

by CHIRANA T.Injecta, a.s.

Ref CHP338Model Infusion 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 Number858601504INFUSIONSET12XF Basic UDI-DI 08586015048395UDI-DIDate5 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/QS-071 Expiring Expires in 334 days

    Quality management system EU MDR

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Infusion set for single use
Model / Reference
Infusion set, CHP338
Primary DI / UDI-DI
08586015048395
Basic UDI-DI
858601504INFUSIONSET12XF
Direct Marketing DI
08586015048395
EMDN Code
A03010103 Infusion controllers with flow regulator
Device Class
Class IIb
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
SK-MF-000003702

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

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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