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Kenz R112-27R

by Isd Meditech Sdn. Bhd. Malaysia EUDAMED

Ref SK-11230-16RModel SKYMED EMDN Z12059009

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955101981MCRP-SMPY Basic UDI-DIDate7 Mar 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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Medical Chart Recording Paper
Model / Reference
SKYMED, SK-11230-16R
Primary DI / UDI-DI
09551019815648
Basic UDI-DI
955101981MCRP-SMPY
Direct Marketing DI
09551019815648
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 87121581-0677-43a2-9fcc-7fce0224d745 61 fields · synced 22 Oct 2026