Digital Ultrasonic Diagnostic Imaging System
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 10 variants
Ref DP-15Model DP-10, DP-10T, DP-11, DP-15, DP-18, DP-20, DP-20T, DP-21, DP-25, DP-28, DP-30, DP-30T, DP-36
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69449040AB050100135N 06936415978013 | Date23 Oct 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Digital Ultrasonic Diagnostic Imaging System
- Model / Reference
- DP-10, DP-10T, DP-11, DP-15, DP-18, DP-20, DP-20T, DP-21, DP-25, DP-28, DP-30, DP-30T, DP-36
- Primary DI / UDI-DI
- 06936415978013
- Basic UDI-DI
- 69449040AB050100135N
- EMDN Code
- Z11040103 Portable ultrasound scanners
- Device Class
- Class IIa
- EU 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
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