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Basic X8 Predictable

by Humanelektronik GmbH Germany EUDAMED

Ref 407003Model HE Kommunikator Basic X

EMDN Y214209

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426076432HEKOMMUNBASICXEZ Basic UDI-DIDate5 Dec 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Basic X8 GoTalkNow
Model / Reference
HE Kommunikator Basic X, 407003
Primary DI / UDI-DI
04260764320240
Basic UDI-DI
426076432HEKOMMUNBASICXEZ
Direct Marketing DI
04260764320240
EMDN Code
Y214209 Alphabetic and symbolic communicators
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000013990

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 61a2193d-3065-461b-98e7-b91c539f5045 61 fields · synced 22 Oct 2026