Diagnostic Ultrasound System
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 281 variants
Ref DC-95 ExpModel DC-80A/ DC-80A Exp/ DC-80A Pro/ DC-8X/ DC-8Q/ DC-81/ DC-82/DC-90/ DC-90 Exp/ DC-90 Pro/DC-95/ DC-95 Exp/DC-95 Pro/ DC-88/ DC-88 Exp/ DC-88 Pro/ DC-MV/ DC-90S/ DC-90T/ DC-90 Nova/ DC-95S/ DC-95T/ DC-95 Nova/ DC-88S/ DC-88T/ DC-88 Nova/ DC-MS, DC-80A, DC-80A Exp, DC-80A Pro, DC-8X, DC-8Q, DC-81, DC-82, DC-90, DC-90 Exp, DC-90 Pro, DC-95, DC-95 Exp, DC-95 Pro, DC-88, DC-88 Exp, DC-88 Pro, DC-MV, DC-90S, DC-90T, DC-90 Nova, DC-95S, DC-95T, DC-95 Nova, DC-88S, DC-88T, DC-88 Nova, DC-MS
Active
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 | Number69449040DC-90**********SV 06936415972592 | Date20 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- Withdrawn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
- DC-80A/ DC-80A Exp/ DC-80A Pro/ DC-8X/ DC-8Q/ DC-81/ DC-82/DC-90/ DC-90 Exp/ DC-90 Pro/DC-95/ DC-95 Exp/DC-95 Pro/ DC-88/ DC-88 Exp/ DC-88 Pro/ DC-MV/ DC-90S/ DC-90T/ DC-90 Nova/ DC-95S/ DC-95T/ DC-95 Nova/ DC-88S/ DC-88T/ DC-88 Nova/ DC-MS, DC-95 Exp, DC-80A, DC-80A Exp, DC-80A Pro, DC-8X, DC-8Q, DC-81, DC-82, DC-90, DC-90 Exp, DC-90 Pro, DC-95, DC-95 Pro, DC-88, DC-88 Exp, DC-88 Pro, DC-MV, DC-90S, DC-90T, DC-90 Nova, DC-95S, DC-95T, DC-95 Nova, DC-88S, DC-88T, DC-88 Nova, DC-MS
- Primary DI / UDI-DI
- 06936415972592
- Basic UDI-DI
- 69449040DC-90**********SV, 69449040AB050100235R
- EMDN Code
- Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
- 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