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Amplivox Otosure

by Amplivox, Ltd.

Ref 8508019

Amplivox Otosure is a device classified as Class IIa in the EU and Class II in the US made by Amplivox, Ltd., registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 506048890_8508019_FF) and listed in FDA GUDID since 22 Dec 2023 (UDI-DI 05060488901409), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506048890_8508019_FF Basic UDI-DI 05060488901409UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060488901409 UDI-DI Date22 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506048890_8508019_FF registered 3 Aug 2026 Active
  • FDA GUDID UDI-DI 05060488901409 listed 22 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060488901409
  2. Registered EUDAMED 506048890_8508019_FF

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Otosure EUDAMED
Amplivox GUDID
Generic name
Vestibulo-auditory analysis system
Model / reference
8508019 EUDAMED
Otosure GUDID
Primary DI / UDI-DI
05060488901409
Basic UDI-DI
506048890_8508019_FF
Direct marketing DI
05060488901409
FDA product code
EWO
EMDN code
Z121401 Audiometers
GMDN term
Vestibulo-auditory analysis system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1050
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8508019
GUDID
Otosure
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Vestibulo-auditory analysis system

Similar devices in this category

Other devices filed under AUDIOMETERS.

Other devices from Amplivox, Ltd.

See all devices from Amplivox, Ltd. →

Properties

  • Measuring function
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)