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Ear Coupler Cable 100970

by PATH medical GmbH

Ref 100970Model ECC

Ear Coupler Cable 100970 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 28 May 2026 (Basic UDI-DI 0426022ECC-2a5Z), cleared under FDA 510(k) K133012 on 9 Jun 2014 and listed in FDA GUDID since 21 Jan 2020 (UDI-DI 04260223143595), active as of 23 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 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 Number0426022ECC-2a5Z Basic UDI-DI 04260223143595UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260223143595 UDI-DI Date21 Jan 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-2a5Z registered 28 May 2026 Active
  • FDA 510(k) K133012 decided 9 Jun 2014 Active
  • FDA GUDID UDI-DI 04260223143595 listed 21 Jan 2020 Listed

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 04260223143595
  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 0426022ECC-2a5Z

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
Pecc-Hp EUDAMED
Ear Coupler Cable GUDID
Generic name
Evoked-potential audiometer
Model / reference
100970, ECC
Primary DI / UDI-DI
04260223143595
Basic UDI-DI
0426022ECC-2a5Z
510(k) Number
FDA product code
GWJ
EMDN code
Z12140302 Evoked potential audiometry equipments
GMDN term
Evoked-potential audiometer
Device class
Class IIa 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 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 EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS.

Other devices from PATH medical GmbH

See all devices from PATH medical GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)