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AuDX Device with touchscreen 100098-AU

by PATH medical GmbH

Ref 100098-AUModel SOH100098

AuDX Device with touchscreen 100098-AU is a device classified as Class IIa in the EU and Class II in the US made by PATH medical GmbH, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 0426022Sentiero-2aHJ), cleared under FDA 510(k) K133012 on 9 Jun 2014 and listed in FDA GUDID since 10 Apr 2018 (UDI-DI 04260223143281), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

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

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133012

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0426022Sentiero-2aHJ Basic UDI-DI 04260223143281UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260223143281 UDI-DI Date10 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK133012 Date9 Jun 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0426022Sentiero-2aHJ registered 27 May 2026 Active
  • FDA 510(k) K133012 decided 9 Jun 2014 Active
  • FDA GUDID UDI-DI 04260223143281 listed 10 Apr 2018 Listed

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0403-2024 FDA Class II initiated 26 Sep 2023
    • Ongoing Z-0401-2024 FDA Class II initiated 26 Sep 2023
    • Ongoing Z-0404-2024 FDA Class II initiated 26 Sep 2023
    • Ongoing Z-0402-2024 FDA Class II initiated 26 Sep 2023

    Affected lots of product may experience technical distortions to a greater extent than expected.

Timeline

7 dated events

  1. Cleared FDA 510(k) K133012
  2. Listed FDA GUDID 04260223143281
  3. Recall initiated FDA recalls Z-0403-2024
  4. Recall initiated FDA recalls Z-0401-2024
  5. Recall initiated FDA recalls Z-0404-2024
  6. Recall initiated FDA recalls Z-0402-2024
  7. Registered EUDAMED 0426022Sentiero-2aHJ

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
AuDX EUDAMED
AuDX Device with touchscreen GUDID
Generic name
Evoked-potential audiometer
Device name
Sentiero
Model / reference
100098-AU, SOH100098
Primary DI / UDI-DI
04260223143281
Basic UDI-DI
0426022Sentiero-2aHJ
510(k) Number
FDA product code
EWO, GWJ
EMDN code
Z121401, Z12149001
GMDN term
Evoked-potential audiometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.1050, 882.1900
EU registration type
Standard device
EU market of registration
Germany
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 audiometer

Cleared under the same submission (K133012)

and 8 more cleared under K133012

Similar devices in this category

Other devices filed under OTOACOUSTIC EMISSIONS EQUIPMENT.

Other devices from PATH medical GmbH

See all devices from PATH medical GmbH →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)