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CloudHolter

by Oy Diagnostic Devices Development Finland EUDAMED

Ref 05

EMDN Z12050403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-FI-CA01-2017-1781GJ Basic UDI-DIDate3 Dec 2021RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
05
Primary DI / UDI-DI
D-FI-CA01-2017-1781GJ
Basic UDI-DI
B-FI-CA01-2017-1781GJ
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
FI-MF-000017197

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED dc9eb4a4-ab47-4f7d-b82c-3c264f110b5e 61 fields · synced 24 Oct 2026