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Medical X-ray Radiography Fluoroscopy High Frequency High Voltage Generator
EUDAMEDClass IIb (EU MDR)
Ref PSG-RF50Model PSG-RF50, PSG-RF65, PSG-RF80
Identity
- Trade Name
- Medical X-ray Radiography Fluoroscopy High Frequency High Voltage Generator EUDAMED
- Device Name
- Medical X-ray Radiography Fluoroscopy High Frequency High Voltage Generator EUDAMED
- Model / Reference
- PSG-RF50, PSG-RF65, PSG-RF80 EUDAMEDPSG-RF50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973858210232 EUDAMED
- Basic UDI-DI
- 6973858212b0102010028E EUDAMED
- Direct Marketing DI
- 06973858210232 EUDAMED
- EMDN Code
- Z11039011 HIGH VOLTAGE X-RAY GENERATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Diagnostic x-ray system generator, stationary
Medical X-ray Radiography Fluoroscopy High Frequency High Voltage Generator by Suzhou Powersite Electric Co., Ltd. — Class IIb — MDR — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6973858212b0102010028E | Class IIb | Active |
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Manufacturer
- Manufacturer
- Suzhou Powersite Electric Co., Ltd.
- EUDAMED SRN
- CN-MF-000018914
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 4648ccd7-93f5-456b-b78f-15cf0174340b 61 fields · synced Jun 18, 2026