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Omnitrope Pen 10

by BD Medical – Pharmaceutical Systems, Becton, Dickinson and Company 2 variants

Ref 42786578

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-0038290490483LHX Basic UDI-DI D-0038290490483LHXUDI-DIDate19 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
42786578
Primary DI / UDI-DI
D-0038290490483LHX
Basic UDI-DI
B-0038290490483LHX
EMDN Code
A018006 Hypodermic needles pen injectors
Device Class
Class IIb
EU market of registration
Cyprus

Manufacturer details

EUDAMED SRN
US-MF-000016937
Authorised representative
Becton Dickinson France SAS FR-AR-000011519

Other devices from BD Medical – Pharmaceutical Systems, Becton, Dickinson and Company

Properties

  • Administering Medicine
  • Measuring Function

Other properties (11)

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