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Digital Dental X-ray Imaging System

by Shanghai Handy Medical Equipment Co., Ltd. China EUDAMED

Ref HDR-600BModel HDR-500, HDR-500A, HDR-500B, HDR-500C, HDR-600, HDR-600A, HDR-600B, HDR-600C, HDR-360, HDR-460, HDR-380, HDR-490, HDR-330, HDR-480 EMDN Z1103040102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697313088HDRQM Basic UDI-DIDate8 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
HDR-500, HDR-500A, HDR-500B, HDR-500C, HDR-600, HDR-600A, HDR-600B, HDR-600C, HDR-360, HDR-460, HDR-380, HDR-490, HDR-330, HDR-480
Primary DI / UDI-DI
06973130880139
Basic UDI-DI
697313088HDRQM
EMDN Code
Z1103040102 Equipment for digital endoral radiology
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000030072
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Dental digital imaging sensor, intraoral

Other devices from Shanghai Handy Medical Equipment Co., Ltd.

See all devices from Shanghai Handy Medical Equipment Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED eb00ef48-ed97-4e73-a9eb-d280f081457c 61 fields · synced 23 Oct 2026