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Helix

by Ear-Technic GmbH Germany EUDAMED

Ref 142D01-02350103, 160D02 - 07010124, 161D01 - 07020150, 160D01 - 07010130, 134D01-02340171, 133D01-02330186, 171D01 - 08040113, 160D01 - 07010103, 128D02-02290184, 133D01-02330171, 134D01-02340196, 134D02-02340134, 134D02-02340129, 142D01-02350186, 160D02 - 07010132, 133D01-02330192, 134D01-02340164, 160D02 - 07010118, 160D01 - 07010121, 113D02-022101134, 141D01-02360196, 161D01 - 07020137, 134D01-02340192, 133D01-02330170, 161D01 - 07020141, 142D01-02350164, 142D02-02350134, 160D01 - 07010110, 160D01 - 07010119, 160D02 - 07010135, 133D02-02330134, 113D02-022101117, 132D02-02310191, 160D02 - 07010123, 160D01 - 07010102, 170D02-08010102, 160D02 - 07010136, 113D01-022101149, 171D01-08020108, 126D01-02270171, 161D01 - 07020149, 160D02 - 07010108, 161D01 - 07020144, 160D02 - 07010125, 142D01-02350171, 160D02 - 07010133, 161D01 - 07020148, 160D02 - 07010106, 160D01 - 07010120, 171D01-08020106, 161D01 - 07020138Model ITEKIT Hearing Aids Series, BTE Hearing Aids Series, ITE Hearing Aids Series, TIE Hearing Aids Series EMDN Y2145060203

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426245117ITE283 Basic UDI-DIDate8 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
ITE KIT Family
BTE Family
ITE Family
TIE Family
Model / Reference
ITEKIT Hearing Aids Series, 142D01-02350103, BTE Hearing Aids Series, 160D02 - 07010124, 161D01 - 07020150, 160D01 - 07010130, ITE Hearing Aids Series, 134D01-02340171, 133D01-02330186, 171D01 - 08040113, 160D01 - 07010103, TIE Hearing Aids Series, 128D02-02290184, 133D01-02330171, 134D01-02340196, 134D02-02340134, 134D02-02340129, 142D01-02350186, 160D02 - 07010132, 133D01-02330192, 134D01-02340164, 160D02 - 07010118, 160D01 - 07010121, 113D02-022101134, 141D01-02360196, 161D01 - 07020137, 134D01-02340192, 133D01-02330170, 161D01 - 07020141, 142D01-02350164, 142D02-02350134, 160D01 - 07010110, 160D01 - 07010119, 160D02 - 07010135, 133D02-02330134, 113D02-022101117, 132D02-02310191, 160D02 - 07010123, 160D01 - 07010102, 170D02-08010102, 160D02 - 07010136, 113D01-022101149, 171D01-08020108, 126D01-02270171, 161D01 - 07020149, 160D02 - 07010108, 161D01 - 07020144, 160D02 - 07010125, 142D01-02350171, 160D02 - 07010133, 161D01 - 07020148, 160D02 - 07010106, 160D01 - 07010120, 171D01-08020106, 161D01 - 07020138
Primary DI / UDI-DI
04262451171234, 04262451170138, 04262451171067, 04262451170916, 04262451171159, 04262451171104, 04262451172545, 04262451170794, 04262451170008, 04262451171098, 04262451171203, 04262451170251, 04262451170244, 04262451171227, 04262451170152, 04262451171128, 04262451171197, 04262451171937, 04262451170879, 04262451170374, 04262451171326, 04262451170930, 04262451171180, 04262451170190, 04262451170978, 04262451171258, 04262451170299, 04262451170817, 04262451170855, 04262451171968, 04262451170213, 04262451170350, 04262451171975, 04262451170121, 04262451170787, 04262451172279, 04262451170039, 04262451171333, 04262451172507, 04262451170022, 04262451171050, 04262451170763, 04262451171005, 04262451170145, 04262451171210, 04262451170169, 04262451171043, 04262451170077, 04262451170862, 04262451172262, 04262451170947
Basic UDI-DI
426245117ITE283, 426245117BTE16G, 426245117ITE17Z, 426245117TIE18P
EMDN Code
Y2145060203, Y2145060101, Y2145060202, Y2145060201, Y21450603, Y2145060204, Y2145060102
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 (51)

  • EUDAMED 37efb163-e8b7-4578-bea6-80e6fed02358 61 fields · synced 22 Oct 2026
  • EUDAMED 04262451170138|426245117BTE16G 61 fields · synced 11 May 2026
  • EUDAMED 04262451171067|426245117ITE283 61 fields · synced 11 May 2026
  • EUDAMED 04262451170916|426245117ITE283 61 fields · synced 16 May 2026
  • EUDAMED 04262451171159|426245117ITE17Z 61 fields · synced 16 May 2026
  • EUDAMED 04262451171104|426245117ITE283 61 fields · synced 16 May 2026
  • EUDAMED 04262451172545|426245117ITE17Z 61 fields · synced 16 May 2026
  • EUDAMED 04262451170794|426245117ITE283 61 fields · synced 16 May 2026
  • EUDAMED 04262451170008|426245117TIE18P 61 fields · synced 16 May 2026
  • EUDAMED 04262451171098|426245117ITE17Z 61 fields · synced 16 May 2026
  • EUDAMED 04262451171203|426245117ITE283 61 fields · synced 16 May 2026
  • EUDAMED 04262451170251|426245117BTE16G 61 fields · synced 16 May 2026
  • EUDAMED 04262451170244|426245117BTE16G 61 fields · synced 17 May 2026
  • EUDAMED 04262451171227|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451170152|426245117BTE16G 61 fields · synced 17 May 2026
  • EUDAMED 04262451171128|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451171197|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451171937|426245117TIE18P 61 fields · synced 17 May 2026
  • EUDAMED 04262451170879|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451170374|426245117BTE16G 61 fields · synced 17 May 2026
  • EUDAMED 04262451171326|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451170930|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451171180|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451170190|426245117BTE16G 61 fields · synced 17 May 2026
  • EUDAMED 04262451170978|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451171258|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451170299|426245117BTE16G 61 fields · synced 17 May 2026
  • EUDAMED 04262451170817|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451170855|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451171968|426245117TIE18P 61 fields · synced 17 May 2026
  • EUDAMED 04262451170213|426245117BTE16G 61 fields · synced 17 May 2026
  • EUDAMED 04262451170350|426245117BTE16G 61 fields · synced 17 May 2026
  • EUDAMED 04262451171975|426245117TIE18P 61 fields · synced 17 May 2026
  • EUDAMED 04262451170121|426245117BTE16G 61 fields · synced 17 May 2026
  • EUDAMED 04262451170787|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451172279|426245117BTE16G 61 fields · synced 17 May 2026
  • EUDAMED 04262451170039|426245117TIE18P 61 fields · synced 17 May 2026
  • EUDAMED 04262451171333|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451172507|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451170022|426245117ITE17Z 61 fields · synced 17 May 2026
  • EUDAMED 04262451171050|426245117ITE283 61 fields · synced 17 May 2026
  • EUDAMED 04262451170763|426245117TIE18P 61 fields · synced 18 May 2026
  • EUDAMED 04262451171005|426245117ITE17Z 61 fields · synced 18 May 2026
  • EUDAMED 04262451170145|426245117BTE16G 61 fields · synced 18 May 2026
  • EUDAMED 04262451171210|426245117ITE17Z 61 fields · synced 18 May 2026
  • EUDAMED 04262451170169|426245117BTE16G 61 fields · synced 18 May 2026
  • EUDAMED 04262451171043|426245117ITE17Z 61 fields · synced 18 May 2026
  • EUDAMED 04262451170077|426245117BTE16G 61 fields · synced 18 May 2026
  • EUDAMED 04262451170862|426245117ITE283 61 fields · synced 18 May 2026
  • EUDAMED 04262451172262|426245117ITE283 61 fields · synced 18 May 2026
  • EUDAMED 04262451170947|426245117ITE283 61 fields · synced 18 May 2026