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Ovaleap Pen

by Owen Mumford Ltd 5 variants

Ref P002602A5

Ovaleap Pen (P002602A5) is a medical device (EU MDD Class IIa; EMDN category hypodermic needles pen injectors) made by Owen Mumford Ltd, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-50161892601166), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-50161892601166 Basic UDI-DI 50161892601166UDI-DIDate27 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
P002602A5
Primary DI / UDI-DI
50161892601166
Basic UDI-DI
B-50161892601166
EMDN code
A018006 Hypodermic needles pen injectors
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000021000
Authorised representative
Owen Mumford GmbH DE-AR-000020700

Similar devices in this category

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Properties

  • Administering medicine
Other properties (11, all answered No)