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Zentron Fiale

by Biodue SpA

Ref BD05

Zentron Fiale (BD05) is a Class IIa device made by Biodue SpA, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-DMS0000040GM), 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-DMS0000040GM Basic UDI-DI Date3 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Trade name
Zentron Fiale
ZENTRON FIALE c/r
Model / reference
BD05
Primary DI / UDI-DI
D-DMS0000040GM, D-DMS0000041GP
Basic UDI-DI
B-DMS0000040GM, B-DMS0000041GP
EMDN code
Q030199 Nasopharyngeal 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

Similar devices in this category

Other devices filed under NASOPHARYNGEAL DEVICES - OTHER.

Other devices from Biodue SpA

See all devices from Biodue SpA →

Properties

Other properties (12, all answered No)