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Ear Coupler Set 100890-5

by PATH medical GmbH

Ref 100890-5

Ear Coupler Set 100890-5 is a device classified as Class I in the EU and Class II in the US made by PATH medical GmbH, registered in EUDAMED on 31 May 2022 (Basic UDI-DI 0426022ECC-1BM), cleared under FDA 510(k) K133012 on 9 Jun 2014 and listed in FDA GUDID since 27 Jun 2020 (UDI-DI 04260223145315), active as of 25 Oct 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

4 ongoing

Recall on shared 510(k) K133012; other models may be affected

Documents

None, self-declared

Class I: no certifier involved

510(k) K133012

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0426022ECC-1BM Basic UDI-DI 04260223145315UDI-DIDate31 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number04260223145315 UDI-DI Date27 Jun 2020ListedStatusListed 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 0426022ECC-1BM registered 31 May 2022 Active
  • FDA 510(k) K133012 decided 9 Jun 2014 Active
  • FDA GUDID UDI-DI 04260223145315 listed 27 Jun 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0403-2024 FDA Class II initiated 26 Sep 2023 on shared 510(k) K133012
    • Ongoing Z-0401-2024 FDA Class II initiated 26 Sep 2023 on shared 510(k) K133012
    • Ongoing Z-0404-2024 FDA Class II initiated 26 Sep 2023 on shared 510(k) K133012
    • Ongoing Z-0402-2024 FDA Class II initiated 26 Sep 2023 on shared 510(k) K133012

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

7 dated events

  1. Cleared FDA 510(k) K133012
  2. Listed FDA GUDID 04260223145315
  3. Registered EUDAMED 0426022ECC-1BM
  4. Recall initiated FDA recalls Z-0403-2024
  5. Recall initiated FDA recalls Z-0401-2024
  6. Recall initiated FDA recalls Z-0404-2024
  7. Recall initiated FDA recalls Z-0402-2024

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
Ear Cups (ECC) EUDAMED
Ear Coupler Set GUDID
Generic name
Evoked-potential audiometer
Device name
Ear Coupler (PATH)
Model / reference
100890-5
Primary DI / UDI-DI
04260223145315
Basic UDI-DI
0426022ECC-1BM
Unit of use DI
04260223143410
510(k) Number
FDA product code
GWJ
EMDN code
Z12140380 Evoked potential audiometry instruments - hardware accessories
GMDN term
Evoked-potential audiometer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS.

Other devices from PATH medical GmbH

See all devices from PATH medical GmbH →

Properties

  • Single use
  • Prescription use
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)