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Osia 3 Sound Processor Kit - Paediatric

by Cochlear Europe Ltd

Ref BQDEUModel PPF10_4

Osia 3 Sound Processor Kit - Paediatric (BQDEU) is a Class III device made by Cochlear Europe Ltd, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 9321502PPF10_4NA), active as of 7 Nov 2026.

Active European Union

CE MDR

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/MDR Number9321502PPF10_4NA Basic UDI-DI 09321502086608UDI-DIDate22 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
PPF10_4, BQDEU
Primary DI / UDI-DI
09321502086608
Basic UDI-DI
9321502PPF10_4NA
EMDN code
J0380 Auditory active-implantable devices - accessories
Device class
Class III
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
The procedure packs are intended to be used by qualified hearing care professionals during the following situations: • implant surgical procedures • activation and initial fitting process of a compatible implant system • during an upgrade session The pack contains the sterile (where applicable) and non-sterile components needed to perform the surgical implantation, post-implant activation procedures, or the upgrade to a next generation sound processor. All components are intended exclusively for use with implant models listed in the Instructions for Use accompanying the individual medical devices and must be used strictly in accordance with the manufacturers' intended purpose. All devices included in the proposed procedure packs retain their original intended purposes as defined by their respective manufacturers. The pack does not alter the function, intended use, or safety profile of any included device.

Manufacturer details

EUDAMED SRN
UK-PR-000052109

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Properties

Other properties (2, all answered No)