Skip to content

Fukuda Cardisuny ECG Roll (50mm X 30M)

by Isd Meditech Sdn. Bhd. 4 variants

Ref SK-5030-16R4Model SKYMED

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955101981MCRP-SMPY Basic UDI-DI 09551019815884UDI-DIDate7 Mar 2025RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Medical Chart Recording Paper
Model / Reference
SKYMED, SK-5030-16R4
Primary DI / UDI-DI
09551019815884
Basic UDI-DI
955101981MCRP-SMPY
Direct Marketing DI
09551019815884
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.

See all devices from Isd Meditech Sdn. Bhd. →

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