Skip to content

BTE Hearing Aids

by Austar Hearing Science & Technology (Xiamen) Co., Ltd. 23 variants

Ref EP05U

Active European Union

CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06943786001448 Basic UDI-DI 06943786001448UDI-DIDate19 Aug 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
EP05U
Primary DI / UDI-DI
06943786001448
Basic UDI-DI
B-06943786001448
EMDN Code
Y2145060102 Behind-the-ear hearing aids with receiver in the canal (ric, rite)
Device Class
Class IIa
EU market of registration
Austria

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

See all devices from Austar Hearing Science & Technology (Xiamen) Co., Ltd →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No