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Medical X-ray Radiography Fluoroscopy High Frequency High Voltage Generator

by Suzhou Powersite Electric Co., Ltd. 6 variants

Ref Opera G500IQModel PSG-RF50, PSG-RF65, PSG-RF80

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6973858212b0102010028E Basic UDI-DI 06973858210553UDI-DIDate19 Mar 2026RegisteredStatusActive

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  • Withdrawn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
PSG-RF50, PSG-RF65, PSG-RF80, Opera G500IQ
Primary DI / UDI-DI
06973858210553
Basic UDI-DI
6973858212b0102010028E
Direct Marketing DI
06973858210553
EMDN Code
Z11039011 High voltage x-ray generators
Device Class
Class IIb
EU 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

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