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Mowana Auto Duo

by Pentamaster MediQ Sdn. Bhd. 4 variants

Ref 805.M3105.DSModel MOWANA

Active European Union

CE MDR

Valid until

7 Aug 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2026-MDR/QS-001/A Date19 Oct 2026IssuedStatusActive expires 7 Aug 2029

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2026-MDR/QS-001 Active Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    5 Jan 2026
    Expires
    7 Aug 2029
  • 2026-MDR/QS-001/A Active Supplemented

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    19 Oct 2026
    Expires
    7 Aug 2029
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Hypodermic Pen Needles
Model / Reference
MOWANA, 805.M3105.DS
Primary DI / UDI-DI
09551014891333
Basic UDI-DI
955101489PENNEEDLEPS
Direct Marketing DI
09551014891333
EMDN Code
A0101010201 Hypodermic pen needles, with safety systems
Device Class
Class IIa
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 Safety

    Class IIb

  • Kawana Ns

    Class IIb

  • Kawana Ns

    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