Wireless Probe Type Ultrasound Scanner
by Guangzhou Sonostar Technologies Co., Ltd. United States EUDAMED
Ref MD1202_16Model UProbe-L、UProbe-C、BProbe、CProbe-C、CProbe-L、CProbe-CL、CProbe-CT EMDN Z11040106
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697067275WirelessProbeR7 | Date22 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 28620203593-01 Supplemented
Quality management system EU MDR
- Notified body
- Intertek Medical Notified Body AB 2862
- Issued
- 1 Jun 2026
- Expires
- 18 Nov 2029
- Reason
- Add device or group
Specification
- Model / Reference
- UProbe-L、UProbe-C、BProbe、CProbe-C、CProbe-L、CProbe-CL、CProbe-CT, MD1202_16
- Primary DI / UDI-DI
- 06970672751088
- Basic UDI-DI
- 697067275WirelessProbeR7
- Direct Marketing DI
- 06970672751088
- EMDN Code
- Z11040106 Handheld ultrasound scanners
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000030303
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Guangzhou Sonostar Technologies Co., Ltd.
See all devices from Guangzhou Sonostar Technologies Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Implantable: 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 06970672751088|697067275WIRELESSPROBER7