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Digital Dental X-ray Imaging System

by Shanghai Handy Medical Equipment Co., Ltd. 8 variants

Ref HDR-500, HDR-600C, HDR-500B, HDR-600, HDR-500A, HDR-480, HDR-460Model 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

Active European Union

CE MDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697313088HDRQM Basic UDI-DI Date8 Apr 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

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
06973130880030, 06973130880146, 06973130880108, 06973130880047, 06973130880092, 06973130880276, 06973130880078
Basic UDI-DI
697313088HDRQM
EMDN Code
Z1103040102 Equipment for digital endoral radiology
Device Class
Class IIa
EU 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

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