U8 Exp
by Sonoscape Medical Corp. China EUDAMED
Ref --Model U8 Exp
EMDN Z11040104
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69458686U1028SV | Date25 Sep 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Endoscopic Ultrasonic System
- Model / Reference
- U8 Exp, --
- Primary DI / UDI-DI
- 06945868612559
- Basic UDI-DI
- 69458686U1028SV
- EMDN Code
- Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
- 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 (12)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 0a91c6a7-e47a-4fd4-b714-466642b3d5bf