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Mammography

by Sino Medical-Device Technology Co., Ltd 12 variants

Ref Navigator DR CareModel Navigator DR Care, Navigator DR Care M

Active European Union

CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06950291110466 Basic UDI-DI 06950291110466UDI-DIDate21 Sep 2023RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Mammography
Model / Reference
Navigator DR Care, Navigator DR Care M
Primary DI / UDI-DI
06950291110466
Basic UDI-DI
B-06950291110466, 69502911DR3YB
Direct Marketing DI
06950291110466
EMDN Code
Z11030202 Digital mammography systems
Device Class
Class IIb
EU market of registration
Poland
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

  • 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