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Koalys Consult

by Koalys Technologies ltd.

Ref (01)0729001782001

Koalys Consult ((01)0729001782001) is a device classified as Class IIa in the EU and Class II in the US made by Koalys Technologies Ltd, registered in EUDAMED on 21 Feb 2026 (Basic UDI-DI B-07290017820019) and listed in FDA GUDID since 2 Dec 2018 (UDI-DI 07290017820019), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290017820019 Basic UDI-DI 07290017820019UDI-DIDate21 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290017820019 UDI-DI Date2 Dec 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07290017820019 registered 21 Feb 2026 Active
  • FDA GUDID UDI-DI 07290017820019 listed 2 Dec 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290017820019
  2. Registered EUDAMED B-07290017820019

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Koalys Consult EUDAMED
Audyx GUDID
Generic name
Tone audiometer
Model / Ref / Catalog
(01)0729001782001 EUDAMED
2.X GUDID
Primary DI / UDI-DI
07290017820019
Basic UDI-DI
B-07290017820019
FDA product code
EWO
EMDN code
Z121401 Audiometers
GMDN term
Tone audiometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1050
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
(01)0729001782001
GUDID
2.X
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.

Manufacturer details

EUDAMED SRN
IL-MF-000051836
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under AUDIOMETERS.

Properties

  • Premarket exempt
  • Manufacturing date
Other properties (21, all answered No)