Combined High Frequency X-Ray Source
by Suzhou Powersite Electric Co., Ltd. United States EUDAMED
Ref PSM-PD5.6CPEModel PSM-PD3.5CPE, PSM-PD4CPE, PSM-PD5.6CPE, PSM-PD3.5CPEG, PSM-PD4CPEG, PSM-PD5.6CPEG EMDN Z11039011
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6973858212b0102010048J | Date27 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- PSM-PD3.5CPE, PSM-PD4CPE, PSM-PD5.6CPE, PSM-PD3.5CPEG, PSM-PD4CPEG, PSM-PD5.6CPEG
- Primary DI / UDI-DI
- 06973858210447
- Basic UDI-DI
- 6973858212b0102010048J
- Direct Marketing DI
- 06973858210447
- EMDN Code
- Z11039011 High voltage x-ray generators
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000018914
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Suzhou Powersite Electric Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED c2ea3bf1-3cce-4702-80c8-eeb5c11f22f5