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ECG Roll (110mm X 25M)

by Isd Meditech Sdn. Bhd. Malaysia EUDAMED

Ref APP-11025-16R4Model ALPHA-PLUS EMDN Z12059009

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955102627MCRPAPFF Basic UDI-DIDate26 May 2026RegisteredStatusWithdrawn 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  • Withdrawn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European Union — CE/MDR Withdrawn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 · synced 25 Oct 2026

Device Name
Medical chart Recording Paper
Model / Reference
ALPHA-PLUS, APP-11025-16R4
Primary DI / UDI-DI
09551026273134
Basic UDI-DI
955102627MCRPAPFF
Direct Marketing DI
09551026273134
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

Other devices from Isd Meditech Sdn. Bhd.

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED a27ee695-25a7-41e3-8e85-2f379311f7ca 61 fields · synced 25 Oct 2026