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Medical X-ray High Frequency High Voltage Generator
EUDAMEDClass IIb (EU MDR)
Ref PSG-HR65Model PSG-HR32, PSG-HR40, PSG-HR50, PSG-HR65, PSG-HR80
Identity
- Trade Name
- Medical 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-HR65 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973858210188 EUDAMED
- Basic UDI-DI
- 6973858212b0102010018C 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 (1)
- EUDAMED 24f827d8-f1e5-4cd9-8c0d-73657134a688 61 fields · synced May 21, 2026