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Interacoustics Eclipse

by Interacoustics A/S

Ref 8507420

Interacoustics Eclipse 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_8507420_6X) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05711117076677), 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_8507420_6X Basic UDI-DI 05711117076677UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05711117076677 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5711117_8507420_6X registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 05711117076677 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05711117076677
  2. Registered EUDAMED 5711117_8507420_6X

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  • Withdrawn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 Eclipse EUDAMED
Interacoustics GUDID
Generic name
Otoacoustic emission system, line-powered
Device name
Eclipse
Model / reference
8507420 EUDAMED
Eclipse GUDID
Primary DI / UDI-DI
05711117076677
Basic UDI-DI
5711117_8507420_6X
Direct marketing DI
05711117076677
FDA product code
GWJ, EWO
EMDN code
Z12140302, Z12149001
GMDN term
Otoacoustic emission system, line-powered
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1900, 874.1050
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8507420
GUDID
Eclipse
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, line-powered

Similar devices in this category

Other devices filed under EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS.

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)