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Digital Mammography System

by HEDY Medical Device Co., Ltd. China EUDAMED

Ref 06970021438196Model MXR-550

EMDN Z11030202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970021438196LX Basic UDI-DIDate2 Nov 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

Model / Reference
MXR-550, 06970021438196
Primary DI / UDI-DI
D-06970021438196LX
Basic UDI-DI
B-06970021438196LX
EMDN Code
Z11030202 Digital mammography systems
Device Class
Class IIb
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000030128
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from HEDY Medical Device Co., Ltd.

See all devices from HEDY Medical Device Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED b9a683c9-757e-4862-8da9-218f95488235 61 fields · synced 22 Oct 2026