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Medical X-ray High Frequency High Voltage Generator
EUDAMEDClass IIb (EU MDR)
Ref PSG-HR40Model PSG-HR32, PSG-HR40, PSG-HR50, PSG-HR65, PSG-HR80Ref PSG-HR80Ref PSG-HR32Ref PSG-HR50
Identity
- Trade Name
- Medical X-ray High Frequency High Voltage Generator EUDAMEDMedical X-ray High Frequency High Voltage Generator EUDAMED
- Device Name
- Medical X-ray High Frequency High Voltage Generator EUDAMED
- Model / Reference
- PSG-HR32, PSG-HR40, PSG-HR50, PSG-HR65, PSG-HR80 EUDAMEDPSG-HR40 EUDAMEDPSG-HR80 EUDAMEDPSG-HR32 EUDAMEDPSG-HR50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973858210461 EUDAMED06973858210195 EUDAMED06973858210454 EUDAMED06973858210171 EUDAMED
- Basic UDI-DI
- 6973858212b0102010018C EUDAMED
- Direct Marketing DI
- 06973858210454 EUDAMED06973858210171 EUDAMED
- EMDN Code
- Z11039011 HIGH VOLTAGE X-RAY GENERATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 High Frequency High Voltage Generator by Suzhou Powersite Electric Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6973858212b0102010018C | 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 (4)
- EUDAMED 28b73847-fc14-451f-9cbe-77bc98f254eb 61 fields · synced Aug 4, 2026
- EUDAMED b1e58bd4-5819-4de3-bb15-597ef8948fff 61 fields · synced May 17, 2026
- EUDAMED 3787ce87-23ca-47ff-abe2-741a6f063a7d 61 fields · synced May 17, 2026
- EUDAMED e13377b1-c87c-4b3e-a8fb-51e7af6ce5ee 61 fields · synced May 18, 2026