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Ghoto

by Alker medicale S.r.l. Italy EUDAMED

Ref HALKF047V, HALKF051VModel HALKF

EMDN Z12029011

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805127754HALKF8T Basic UDI-DIDate28 Nov 2022RegisteredStatusActive

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
HALKF, HALKF047V, HALKF051V
Primary DI / UDI-DI
08051277540470, 08051277540517
Basic UDI-DI
805127754HALKF8T
Direct Marketing DI
08051277540470
08051277540517
EMDN Code
Z12029011 Optical heaters
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000030943

Other devices from Alker medicale S.r.l.

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 (2)

  • EUDAMED 57cf06d8-9c68-46eb-9a63-106c8b4e3503 61 fields · synced 22 Oct 2026
  • EUDAMED 08051277540517|805127754HALKF8T 61 fields · synced 18 May 2026