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PKG System

by GKC Manufacturing Pty. Ltd. EUDAMED

Active European Union

Ref PKG System

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number93590110GKC20XXEH Basic UDI-DIDate31 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
The Parkinsons KinetiGraph (PKG) System
Model / Reference
PKG System
Primary DI / UDI-DI
09359011000006
Basic UDI-DI
93590110GKC20XXEH
Direct Marketing DI
09359011000006
EMDN Code
Z12062599 Kinematic motion capture analysis systems - other
Device Class
Class IIa
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
AU-MF-000021150
Authorised representative
CEpartner4U NL-AR-000000111

Other devices from Gkc Manufacturing Pty Ltd

See all devices from Gkc Manufacturing Pty Ltd →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No