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KAWANA Safety

by Pentamaster MediQ Sdn. Bhd. 32 variants

Ref 805.K2225.SP.PRIModel KAWANA

Active European Union

CE MDR

Valid until

7 Aug 2029

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 Number955101489KAWANAF9 Basic UDI-DI 09551014891050UDI-DIDate15 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/QS-051/A Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    5 Jan 2026
    Expires
    7 Aug 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Peripheral IV Catheter
Model / Reference
KAWANA, 805.K2225.SP.PRI
Primary DI / UDI-DI
09551014891050
Basic UDI-DI
955101489KAWANAF9
Direct Marketing DI
09551014891050
EMDN Code
C0101010201 Peripheral i.v. catheters, with safety systems, with injection valves
Device Class
Class IIb
EU market of registration
Slovakia

Manufacturer details

EUDAMED SRN
MY-MF-000049132
Authorised representative
Europecert UG (haftungsbeschränkt) DE-AR-000004974

Other devices from Pentamaster MediQ Sdn. Bhd.

  • KAWANA Safety

    Class IIb

  • Kawana Ns

    Class IIb

  • MOWANA™ Auto Duo

    Class II

  • Kawana Ns

    Class IIb

  • Kawana Ns

    Class IIb

  • KAWANA Safety

    Class IIb

See all devices from Pentamaster MediQ Sdn. Bhd. →

Properties

  • Sterile
  • Administering Medicine

Other properties (11)

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