Skip to content

K•hero K•one

by Drop Digital Health S.r.l. Italy EUDAMED

Ref K•ONEModel K•HERO K•ONE

EMDN Z12069082

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0805363013TOTEM_KONEKJ Basic UDI-DIDate25 Feb 2025RegisteredStatusActive

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
K•one
Model / Reference
K•HERO K•ONE, K•ONE
Primary DI / UDI-DI
08053630130007
Basic UDI-DI
0805363013TOTEM_KONEKJ
EMDN Code
Z12069082 Various physiotherapy and rehabilitation instruments - software accessories
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000046691

Other devices from Drop Digital Health 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 (1)

  • EUDAMED dd4ac51a-7bba-4f14-871b-adbed46b1583 61 fields · synced 22 Oct 2026