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Interacoustics Lyra

by Interacoustics A/S

Ref 8507549

Interacoustics Lyra 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_8507549_8B), cleared under FDA 510(k) K191372 on 15 Jul 2019 and listed in FDA GUDID since 29 Oct 2019 (UDI-DI 05711117196313), 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) K191372

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_8507549_8B Basic UDI-DI 05711117196313UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05711117196313 UDI-DI Date29 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191372 Date15 Jul 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5711117_8507549_8B registered 14 Oct 2026 Active
  • FDA 510(k) K191372 decided 15 Jul 2019 Active
  • FDA GUDID UDI-DI 05711117196313 listed 29 Oct 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191372
  2. Listed FDA GUDID 05711117196313
  3. Registered EUDAMED 5711117_8507549_8B

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  • Withdrawn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 Lyra EUDAMED
Interacoustics GUDID
Generic name
Vestibulo-auditory analysis system
Device name
Lyra
Model / reference
8507549 EUDAMED
Lyra GUDID
Primary DI / UDI-DI
05711117196313
Basic UDI-DI
5711117_8507549_8B
Direct marketing DI
05711117196313
510(k) Number
FDA product code
EWO
EMDN code
Z12149001 Otoacoustic emissions equipment
GMDN term
Vestibulo-auditory analysis system
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
8507549
GUDID
Lyra
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: Vestibulo-auditory analysis system

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)