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Medical Monitor

by Xuzhou AKX Electronic Science and Technology co.，Ltd 4 variants

Ref YKD-8024Model YKD-8019；YKD-8022；YKD-8024；YKD-8027；YKD-8032；YKD-8127；YKD-8132；YKD-8155

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697378758SMXS8000ZJ Basic UDI-DI 06973787580536UDI-DIDate25 Jun 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Medical Monitor
Model / Reference
YKD-8019；YKD-8022；YKD-8024；YKD-8027；YKD-8032；YKD-8127；YKD-8132；YKD-8155, YKD-8024
Primary DI / UDI-DI
06973787580536
Basic UDI-DI
697378758SMXS8000ZJ
EMDN Code
Z11900802 Bioimaging viewing monitors
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000031488
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

Other properties (13)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No