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HEKA Bes

by Challenge APS Denmark EUDAMED

Ref HekaBes

EMDN Y214224

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57000022786HekaBesWK Basic UDI-DIDate14 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
HekaBes
Primary DI / UDI-DI
05700002278609
Basic UDI-DI
57000022786HekaBesWK
Direct Marketing DI
05700002278609
EMDN Code
Y214224 Augmentative software
Device Class
Class I
Special Device Type
Software
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000035625

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED a1ca87e3-942e-4eb9-90f0-9cc09d525816 61 fields · synced 22 Oct 2026