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Combined High Frequency X-Ray Source
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref PSM-PD4CPEModel PSM-PD3.5CPE, PSM-PD4CPE, PSM-PD5.6CPE, PSM-PD3.5CPEG, PSM-PD4CPEG, PSM-PD5.6CPEGRef PSM-PD3.5CPERef PSM-PD5.6CPE
Identity
- Trade Name
- Combined High Frequency X-Ray Source EUDAMED
- Device Name
- Combined High Frequency X-Ray Source EUDAMED
- Model / Reference
- PSM-PD3.5CPE, PSM-PD4CPE, PSM-PD5.6CPE, PSM-PD3.5CPEG, PSM-PD4CPEG, PSM-PD5.6CPEG EUDAMEDPSM-PD4CPE EUDAMEDPSM-PD3.5CPE EUDAMEDPSM-PD5.6CPE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973858210287 EUDAMED06973858210294 EUDAMED06973858210447 EUDAMED
- Basic UDI-DI
- 6973858212b0102010048J EUDAMED
- Direct Marketing DI
- 06973858210287 EUDAMED06973858210294 EUDAMED06973858210447 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
Combined High Frequency X-Ray Source by Suzhou Powersite Electric Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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Also classified as Diagnostic x-ray system generator, stationary.
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222258 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 6973858212b0102010048J | 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 cc7cff7d-eec9-45bc-b29c-2b5f3879976a 61 fields · synced Jul 25, 2026
- EUDAMED 6a3634c1-fdb0-4753-8905-781a2990745b 61 fields · synced May 18, 2026
- EUDAMED c2ea3bf1-3cce-4702-80c8-eeb5c11f22f5 61 fields · synced May 18, 2026
- FDA 510(k) K222258 1 fields · synced May 18, 2026