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Mammography

by Sino Medical-Device Technology Co., Ltd China EUDAMED

Ref Navigator DR Plus

EMDN Z11030202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06950291110923 Basic UDI-DIDate21 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Mammography
Model / Reference
Navigator DR Plus
Primary DI / UDI-DI
06950291110923
Basic UDI-DI
B-06950291110923
EMDN Code
Z11030202 Digital mammography systems
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
CN-MF-000007089
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Sino Medical-Device Technology Co., Ltd

See all devices from Sino Medical-Device Technology Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED acb95416-c2b4-49c9-b58a-52845e4e6a61 61 fields · synced 22 Oct 2026