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by Ear-Technic GmbH Germany EUDAMED

Ref 128D02-02290187Model TIE Hearing Aids Series

EMDN Y2145060201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426245117TIE18P Basic UDI-DIDate8 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
TIE Family
Model / Reference
TIE Hearing Aids Series, 128D02-02290187
Primary DI / UDI-DI
04262451170015
Basic UDI-DI
426245117TIE18P
EMDN Code
Y2145060201 Hearing aid in the-ear (ite)
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000043916

Other devices from Ear-Technic GmbH

See all devices from Ear-Technic GmbH →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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

Sources (1)

  • EUDAMED ab9d9c6d-d7c5-4395-b043-ab089f92eda0 61 fields · synced 24 Oct 2026