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Class IIa

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

Ref Class IIaModel 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. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69437860TWS0012B Basic UDI-DI 06943786080009UDI-DIDate2 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06943786080009 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

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

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  • Withdrawn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
Austar
Generic Name
Air-conduction hearing aid, receiver-in-the-ear
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, Class IIa
Primary DI / UDI-DI
06943786080009
Basic UDI-DI
69437860TWS0012B
FDA Product Code
OSM
EMDN Code
Y2145060201 Hearing aid in the-ear (ite)
GMDN Term
Air-conduction hearing aid, receiver-in-the-ear
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
874.3305
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Other devices from Austar Hearing Science & Technology (Xiamen) Co., Ltd

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Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Lot / Batch Number: No
  • Manufacturing Date: No