Digital Radiography System
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref DigiEye 360Model DigiEye 330 / DigiEye 330E / DigiEye 330P / DigiEye 330T / DigiEye 350 / DigiEye 350E / DigiEye 350P / DigiEye 350T / DigiEye 360 / DigiEye 360E / DigiEye 360P / DigiEye 360T
EMDN Z11031101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69449040AB0601000466 | Date26 Oct 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Digital Radiography System
- Model / Reference
- DigiEye 330 / DigiEye 330E / DigiEye 330P / DigiEye 330T / DigiEye 350 / DigiEye 350E / DigiEye 350P / DigiEye 350T / DigiEye 360 / DigiEye 360E / DigiEye 360P / DigiEye 360T, DigiEye 360
- Primary DI / UDI-DI
- 06903053049689
- Basic UDI-DI
- 69449040AB0601000466
- EMDN Code
- Z11031101 Multifunctional systems for direct digital radiology
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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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 d32cca2f-478c-4b7f-b13f-795f83166afe