X25
Part of a family of 116 devices: see the family page
Ref _Model X11 Exp
X25 (_) is a Class IIa device made by Sonoscape Medical Corp., registered in EUDAMED on 13 May 2025 (Basic UDI-DI 69458686U1024SM), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69458686U1024SM 06945868616137 | Date13 May 2025 | StatusActive |
Official records
- EUDAMED public site 69458686U1024SM
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Digital Color Doppler ultrasound System
- Model / reference
- X11 Exp, _
- Primary DI / UDI-DI
- 06945868616137
- Basic UDI-DI
- 69458686U1024SM
- EMDN code
- Z11040103 Portable ultrasound scanners
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000009623
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Similar devices in this category
Other devices filed under PORTABLE ULTRASOUND SCANNERS.
- Sonosite MT Power Supply P33004-04 by Fujifilm Sonosite, Inc.
- SonoSite SII P20500-13R by Fujifilm Sonosite, Inc.
- ACUSON P500 ICE Ultrasound System 11713064 by SIEMENS MEDICAL SOLUTIONS USA, INC.
- Terason uSmart3300 by Teratech Corporation
- Resona I9 Diagnostic Ultrasound System Hepatus 9 by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Ultrasonic Pocket Doppler SD3 Vascular by Edan Instruments, Inc.
- e.C5-1 210_0001 by E-SCOPICS
- Dolphin/4D PVC0201 by VIASONIX LTD
- Falcon/Quad PVC0078 by VIASONIX LTD
- Full Digital Colour Doppler Ultrasonic Diagnostic System / by Wuhan Zoncare Bio-medical Electronics Co., Ltd