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FBM OVULI c/r

by Biodue SpA

Ref BD06

FBM OVULI c/r (BD06) is a Class IIa device made by Biodue SpA, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-DM00000417V5), 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-DM00000417V5 Basic UDI-DI D-DM00000417V5UDI-DIDate5 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
BD06
Primary DI / UDI-DI
D-DM00000417V5
Basic UDI-DI
B-DM00000417V5
EMDN code
U0899 Gynaecological devices - other
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000033115

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Other devices filed under GYNAECOLOGICAL DEVICES - OTHER.

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Properties

Other properties (12, all answered No)