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Interacoustics Callisto

by Interacoustics A/S

Ref 8000361

Interacoustics Callisto 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_8000361_2D) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05711117089189), 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_8000361_2D Basic UDI-DI 05711117089189UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05711117089189 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5711117_8000361_2D registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 05711117089189 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05711117089189
  2. Registered EUDAMED 5711117_8000361_2D

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  • Withdrawn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 Callisto EUDAMED
Interacoustics GUDID
Generic name
Speech audiometer
Device name
Callisto
Model / reference
8000361 EUDAMED
Callisto GUDID
Primary DI / UDI-DI
05711117089189
Basic UDI-DI
5711117_8000361_2D
Direct marketing DI
05711117089189
FDA product code
ETW, EWO
EMDN code
Z121401 Audiometers
GMDN term
Speech audiometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.3310, 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
8000361
GUDID
Callisto
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: Tone audiometerSpeech audiometer

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Properties

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