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ECG Roll (80mm X 25M)

by Isd Meditech Sdn. Bhd. EUDAMED

Withdrawn Not intended for the EU market

Ref SK-8025-13R3Model SKYMED

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955101981MCRP-SMPY Basic UDI-DIDate7 Mar 2025RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Medical Chart Recording Paper
Model / Reference
SKYMED, SK-8025-13R3
Primary DI / UDI-DI
09551019810414
Basic UDI-DI
955101981MCRP-SMPY
Direct Marketing DI
09551019810414
EMDN Code
Z12059009 ECG data management systems
Device Class
Class I

Manufacturer details

EUDAMED SRN
MY-MF-000043531
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

Show 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