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Infant Insert Eartips 3.5mm (bag of 20) 100906-P-20

by PATH medical GmbH EUDAMEDGUDID

Active European Union and United States

Ref 100906-P-20Model ET-IP10mm

Regulatory status

as of 27 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260223147586 UDI-DIDate24 Jul 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number0426022Earphones-17Q Basic UDI-DIDate31 May 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

No notified-body 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
    • 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.

Specification

EUDAMED · GUDID

Trade Name
Infant Ear Tip 3.5mm EUDAMED
Infant Insert Eartips 3.5mm (bag of 20) GUDID
Generic Name
Evoked-potential audiometer
Device Name
Insert Earphone Tip 10mm
Model / Reference
100906-P-20, ET-IP10mm
Primary DI / UDI-DI
04260223147586
Basic UDI-DI
0426022Earphones-17Q
Unit of Use DI
04260223147562
510(k) Number
FDA Product Code
GWJ, ETT, EWO
EMDN Code
Z121401 Audiometers
GMDN Term
Evoked-potential audiometer
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1900, 874.1100, 874.1050
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K133012)

Show all (12)

Other devices from PATH medical GmbH

See all devices from PATH medical GmbH →

Properties

  • Single Use
  • Prescription Use
  • Manufacturing Date

Other properties (21)

  • 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
  • Expiration Date: No