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Hearing Test Feature

by Apple Inc.

Ref Hearing Test Feature 1.X

Hearing Test Feature (Hearing Test Feature 1.X) is a device classified as Class IIa in the EU and Class II in the US made by Apple Inc., registered in EUDAMED on 23 Jan 2025 (Basic UDI-DI 0195949HTTV) and listed in FDA GUDID since 21 Oct 2024 (UDI-DI 00195949149955), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0195949HTTV Basic UDI-DI Date23 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00195949149955 UDI-DI Date21 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0195949HTTV registered 23 Jan 2025 Active
  • FDA GUDID UDI-DI 00195949149955 listed 21 Oct 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00195949149955
  2. Registered EUDAMED 0195949HTTV

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  • Withdrawn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
Hearing Test Feature (HTF)
Generic name
Self-testing tone audiometer
Model / reference
Hearing Test Feature 1.X EUDAMED
Feature version 1.X GUDID
Primary DI / UDI-DI
00195949149955, 00195949149948
Basic UDI-DI
0195949HTTV
Direct marketing DI
00195949149955
00195949149948
FDA product code
EWO
EMDN code
Z12149092 Various ENT instruments - medical device software
GMDN term
Self-testing tone audiometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1050
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Hearing Test Feature 1.X
GUDID
Feature version 1.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
US-MF-000013709
Authorised representative
Apple Distribution International Limited IE-AR-000012406

Similar devices in this category

Other devices filed under VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Apple Inc.

See all devices from Apple Inc. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)