Diagnostic Ultrasound System
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 281 variants
Ref Z8Model DP-60/Z6/ Z6T/ Z6S/ Z6W/ Z6 Pro/ Z6 Expert/ Z8/ Z8S/ Z8 Pro/ Z8 Expert/ Z60/ Z60T/ Z60S/ Z60W/ Z60 Pro/ Z60 Expert/ Z80/ Z80S/ Z80 Pro/ Z80 Expert
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 | Number69449040AB050100155S 06936415911379 | Date18 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- Withdrawn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
- Diagnostic Ultrasound System
- Model / Reference
- DP-60/Z6/ Z6T/ Z6S/ Z6W/ Z6 Pro/ Z6 Expert/ Z8/ Z8S/ Z8 Pro/ Z8 Expert/ Z60/ Z60T/ Z60S/ Z60W/ Z60 Pro/ Z60 Expert/ Z80/ Z80S/ Z80 Pro/ Z80 Expert, Z8
- Primary DI / UDI-DI
- 06936415911379
- Basic UDI-DI
- 69449040AB050100155S
- 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.
See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →
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