S1-6U
by Sonoscape Medical Corp. China EUDAMED
Ref _Model 2P1
EMDN Z110402010301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69458686P1010QK | Date17 Sep 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ultrasonic Transducer
- Model / Reference
- 2P1, _
- Primary DI / UDI-DI
- 06945868615345
- Basic UDI-DI
- 69458686P1010QK
- Direct Marketing DI
- 06945868615345
- EMDN Code
- Z110402010301 Transcutaneous ultrasound sector probes (phased array), two–dimensional
- Device Class
- Class IIa
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000009623
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Sonoscape Medical Corp.
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 08a8814e-0dc3-4451-ad03-f9793e98ae8c