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Hear Box Mobile

by "Centrum Słuchu i Mowy" sp. z o.o. EUDAMED

Active European Union

Ref 1.1.0, 1.1.1Model HearBox v.1

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5906146760APPHBM02ZN Basic UDI-DIDate29 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  • Withdrawn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

Trade Name
Hear Box Mobile
Hear Box
Model / Reference
1.1.0, HearBox v.1, 1.1.1
Primary DI / UDI-DI
05906146760059, 05906146760042
Basic UDI-DI
5906146760APPHBM02ZN, 5906146760HearBoxMD84
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Special Device Type
Software
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000044997

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