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Interacoustics Sera

by Interacoustics A/S

Ref 8107006Model Sera

Interacoustics Sera is an otoacoustic emission system (EU MDR Class IIa; FDA Class II) made by Interacoustics A/S, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 5711117_8107006_47), cleared under FDA 510(k) K173567 on 14 Feb 2018 and listed in FDA GUDID since 23 Mar 2018 (UDI-DI 05711117190823), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173567

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5711117_8107006_47 Basic UDI-DI 05711117190823UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05711117190823 UDI-DI Date23 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173567 Date14 Feb 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5711117_8107006_47 registered 14 Oct 2026 Active
  • FDA 510(k) K173567 decided 14 Feb 2018 Active
  • FDA GUDID UDI-DI 05711117190823 listed 23 Mar 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173567
  2. Listed FDA GUDID 05711117190823
  3. Registered EUDAMED 5711117_8107006_47

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Interacoustics Sera EUDAMED
Interacoustics GUDID
Generic name
Otoacoustic emission system, battery-powered
Model / reference
Sera, 8107006
Primary DI / UDI-DI
05711117190823
Basic UDI-DI
5711117_8107006_47
Direct marketing DI
05711117190823
510(k) Number
FDA product code
GWJ, EWO
EMDN code
Z12140302, Z12149001
GMDN term
Otoacoustic emission system, battery-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 · 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-powered

Cleared under the same submission (K173567)

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)