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Aurilab

by "K&K CONSULTING" Krzysztof Kalinowicz EUDAMED

Active European Union

Ref DW-DModel BTE Hearing Tubes

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number59080238554DW8S Basic UDI-DIDate7 Jul 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  • Withdrawn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

Device Name
AURILAB BTE Hearing Tubes
Model / Reference
BTE Hearing Tubes, DW-D
Primary DI / UDI-DI
05908023854431
Basic UDI-DI
59080238554DW8S
EMDN Code
Y214580 Hearing aids or hearing devices - accessories
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000056504

Other devices from "K&K CONSULTING" Krzysztof Kalinowicz

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