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Medical X-ray High Frequency High Voltage Generator

by Suzhou Powersite Electric Co., Ltd. FDA registration: China EUDAMED

Ref Opera G650DRModel PSG-HR32, PSG-HR40, PSG-HR50, PSG-HR65, PSG-HR80 EMDN Z11039011

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6973858212b0102010018C Basic UDI-DIDate15 Dec 2023RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Model / Reference
PSG-HR32, PSG-HR40, PSG-HR50, PSG-HR65, PSG-HR80, Opera G650DR
Primary DI / UDI-DI
06973858210539
Basic UDI-DI
6973858212b0102010018C
Direct Marketing DI
06973858210539
EMDN Code
Z11039011 High voltage x-ray generators
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000018914
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Suzhou Powersite Electric Co., Ltd.

See all devices from Suzhou Powersite Electric 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 06973858210539|6973858212B0102010018C 61 fields · synced 25 Oct 2026