X-ray Tube Assembly
by Wuhan United Imaging Healthcare Co., Ltd. China EUDAMED
Ref 78010064Model uXT0344
EMDN Z11039012
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697482993uXT0344VA | Date13 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- X-ray Tube Assembly
- Model / Reference
- uXT0344, 78010064
- Primary DI / UDI-DI
- 06974829930616
- Basic UDI-DI
- 697482993uXT0344VA
- EMDN Code
- Z11039012 X-ray tube assembly
- Device Class
- Class IIb
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000030896
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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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 2c04fc75-2c9a-47d2-97ad-f76e5a2b02d2