Skip to content

Anova

by Amplivox Limited

Ref 8538354

Anova (8538354) is a Class IIa device made by Amplivox Ltd, registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 506048890_8538354_HG), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506048890_8538354_HG Basic UDI-DI 05060488903212UDI-DIDate3 Aug 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
8538354
Primary DI / UDI-DI
05060488903212
Basic UDI-DI
506048890_8538354_HG
Direct marketing DI
05060488903212
EMDN code
Z121401 Audiometers
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000025632
Authorised representative
DGS Diagnostics A/S DK-AR-000020996

Similar devices in this category

Other devices filed under AUDIOMETERS.

Properties

  • Measuring function
Other properties (13, all answered No)