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Interacoustics Titan

by Interacoustics A/S

Ref 8514941Model Titan

Interacoustics Titan 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_8514941_7T) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05711117082104), 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_8514941_7T Basic UDI-DI 05711117082104UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05711117082104 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5711117_8514941_7T registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 05711117082104 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05711117082104
  2. Registered EUDAMED 5711117_8514941_7T

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  • Withdrawn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 Titan EUDAMED
Interacoustics GUDID
Generic name
Otoacoustic emission system, battery-powered
Model / reference
Titan, 8514941
Primary DI / UDI-DI
05711117082104
Basic UDI-DI
5711117_8514941_7T
Direct marketing DI
05711117082104
FDA product code
EWO, GWJ, ETY
EMDN code
Z12140302, Z12149005
GMDN term
Otoacoustic emission system, battery-powered
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1050, 882.1900, 874.1090
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: Evoked-potential audiometerOtoacoustic emission system, battery-poweredImpedance audiometer

Similar devices in this category

Other devices filed under EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS.

Other devices from Interacoustics A/S

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Properties

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