Skip to content

Mammography

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

Ref Navigator DR Care MModel Navigator DR Care, Navigator DR Care M

EMDN Z11030202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69502911DR3YB Basic UDI-DIDate7 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Mammography
Model / Reference
Navigator DR Care, Navigator DR Care M
Primary DI / UDI-DI
06950291110473
Basic UDI-DI
69502911DR3YB
Direct Marketing DI
06950291110473
EMDN Code
Z11030202 Digital mammography systems
Device Class
Class IIb
Market of Registration
Greece

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 (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 9095fce3-f354-4d64-b922-3ee759d895d4 61 fields · synced 23 Oct 2026