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Xgk-6508B

by Shenzhen Futurtec Medical Co.，LTD. China EUDAMED

Ref XGK-6508B

EMDN Z12011401

Regulatory status

as of 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697438536XGK-6508BK3 Basic UDI-DIDate10 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
XGK-6508B
Primary DI / UDI-DI
06974385360025
Basic UDI-DI
697438536XGK-6508BK3
Direct Marketing DI
06974385360025
EMDN Code
Z12011401 Surgical navigation system
Device Class
Class IIb
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000034856
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Futurtec Medical Co.，LTD.

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 d771f66b-f1e1-4f90-974c-25c859a79634 61 fields · synced 22 Oct 2026