Pocket Ultrasound System
by Beijing Konted Medical Technology Co., Ltd China EUDAMED
Ref C10XSModel C10 EMDN Z11040106
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697387564C10SU | Date4 Aug 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- CN24/00006331 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 30 Sep 2026
- Expires
- 9 Oct 2029
- Reason
- Change approved
Specification
- Device Name
- Pocket Ultrasound System
- Model / Reference
- C10, C10XS
- Primary DI / UDI-DI
- 06973875640395
- Basic UDI-DI
- 697387564C10SU
- EMDN Code
- Z11040106 Handheld ultrasound scanners
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000024104
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Beijing Konted Medical Technology Co., Ltd
See all devices from Beijing Konted Medical Technology Co., Ltd →
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 06973875640395|697387564C10SU