Diagnostic Ultrasound System
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China(FDA 510(k) applicant) EUDAMED
Ref Nuewa I7 NovaModel Resona I9, Imagyn I9, Nuewa I9 EMDN Z11040104
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69449040AB050100265X | Date20 Oct 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Diagnostic Ultrasound System
- Model / Reference
- Resona I9, Imagyn I9, Nuewa I9, Nuewa I7 Nova
- Primary DI / UDI-DI
- 06903053044714
- Basic UDI-DI
- 69449040AB050100265X
- EMDN Code
- Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
- Device Class
- Class IIa
- 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
See all devices from Shenzhen Mindray Bio-Medical Electronics 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 1e8bd3e3-b4a1-4545-9341-cd97e60198cd