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Medical HAL

by CYBERDYNE Inc. Japan EUDAMED

Ref HAL-ML08-DMWEUModel HAL-ML08

EMDN Z12069002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number04560340093385F4 Basic UDI-DIDate8 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Medical HAL Lower Limb Type
Model / Reference
HAL-ML08, HAL-ML08-DMWEU
Primary DI / UDI-DI
04560340091534
Basic UDI-DI
04560340093385F4
Direct Marketing DI
04560340091534
EMDN Code
Z12069002 Assisted locomotion systems
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000026131
Authorised representative
Cyberdyne Care Robotics GmbH DE-AR-000025326

Other devices from Cyberdyne, Inc.

See all devices from Cyberdyne, Inc. →

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 799bf1ea-015a-453e-9a20-8d616a9fc6f9 61 fields · synced 24 Oct 2026