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Interacoustics OtoRead

by Interacoustics A/S

Ref 8504335Model Otoread

Interacoustics OtoRead is a device classified as Class IIa in the EU and Class II in the US made by Interacoustics A/S, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 5711117_8504335_6B) and listed in FDA GUDID since 10 Nov 2016 (UDI-DI 05711117180459), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5711117_8504335_6B Basic UDI-DI 05711117180459UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05711117180459 UDI-DI Date10 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5711117_8504335_6B registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 05711117180459 listed 10 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05711117180459
  2. Registered EUDAMED 5711117_8504335_6B

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  • Withdrawn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
Interacoustics OtoRead EUDAMED
Interacoustics GUDID
Generic name
Otoacoustic emission system, battery-powered
Model / reference
OtoRead, 8504335
Primary DI / UDI-DI
05711117180459
Basic UDI-DI
5711117_8504335_6B
Direct marketing DI
05711117180459
FDA product code
EWO
EMDN code
Z12149001 Otoacoustic emissions equipment
GMDN term
Otoacoustic emission system, battery-powered
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1050
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Otoacoustic emission system, battery-powered

Similar devices in this category

Other devices filed under OTOACOUSTIC EMISSIONS EQUIPMENT.

Other devices from Interacoustics A/S

See all devices from Interacoustics A/S →

Properties

  • Measuring function
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)