Ultrasound Gels
by Suzhou Leapmed Healthcare Corporation China EUDAMED
Ref Sa10 EMDN Z11049099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number694116500000002373 | Date27 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- EPT 0477.MDR.26/6235 Issued
Quality management system EU MDR
- Notified body
- Notified body 0477
- Issued
- 20 Jul 2026
- Expires
- 25 Mar 2031
Specification
- Device Name
- Ultrasound Gels
- Model / Reference
- Sa10
- Primary DI / UDI-DI
- 06941165062158
- Basic UDI-DI
- 694116500000002373
- EMDN Code
- Z11049099 Various ultrasound instruments - other
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000013964
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Suzhou Leapmed Healthcare Corporation
See all devices from Suzhou Leapmed Healthcare Corporation →
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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 06941165062158|694116500000002373