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In-The-Ear Hearing Aid

by Austar Hearing Science & Technology (Xiamen) Co., Ltd. 20 variants

Ref FHW70-WModel FHW120-W, FHW110-W, FHW100-W, FHW90-W, FHW80-W, FHW70-W, FHW60-W, FHW50-W, FHW40-W, FHW30-W, FHW12-W, FHW11-W, FHW10-W, FHW09-W, FHW08-W, FHW07-W, FHW06-W, FHW05-W, FHW04-W, FHW03-W

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69437860TWS0012B Basic UDI-DI 06943786080054UDI-DIDate2 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
FHW120-W, FHW110-W, FHW100-W, FHW90-W, FHW80-W, FHW70-W, FHW60-W, FHW50-W, FHW40-W, FHW30-W, FHW12-W, FHW11-W, FHW10-W, FHW09-W, FHW08-W, FHW07-W, FHW06-W, FHW05-W, FHW04-W, FHW03-W
Primary DI / UDI-DI
06943786080054
Basic UDI-DI
69437860TWS0012B
EMDN Code
Y2145060201 Hearing aid in the-ear (ite)
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000017842
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

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