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Re5 Parkinson Treatment System

by Re5 ApS EUDAMED

Active European Union

Ref I2010-3/aModel Re5-PTS

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5745000441PTS03Y5 Basic UDI-DIDate26 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Re5-PTS, I2010-3/a
Primary DI / UDI-DI
05745000441037
Basic UDI-DI
5745000441PTS03Y5
Direct Marketing DI
05745000441037
EMDN Code
Z12101105 Magnetic stimulators
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000017805

Other devices from Re5 ApS

Properties

Show properties
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