Skip to content

Ear Cups (ECC)

by PATH MEDICAL GmbH 2 variants

Ref 100890-30

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

4 ongoing

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

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260223145995 UDI-DI Date24 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0426022ECC-1BM Basic UDI-DI 04260223145995UDI-DIDate31 May 2022RegisteredStatusActive

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.

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  • Withdrawn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
Ear Cups (ECC) EUDAMED
Ear Coupler Set GUDID
Generic Name
Evoked-potential audiometer
Device Name
Ear Coupler (PATH)
Model / Reference
100890-30
Primary DI / UDI-DI
04260223145995
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 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

Manufacturer details

EUDAMED SRN
DE-MF-000006935

Other devices from PATH medical GmbH

See all devices from PATH medical GmbH →

Properties

  • Single Use
  • Prescription Use
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No