Intraoral Scanner
by Shenzhen Sunmc Dental Technology Co., Ltd. EUDAMED
Active
Ref 3DS UltraModel SCAN-i5
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697558621IntraoralGC | Date15 Oct 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Intraoral Scanner
- Model / Reference
- SCAN-i5, 3DS Ultra
- Primary DI / UDI-DI
- 16975586210055
- Basic UDI-DI
- 697558621IntraoralGC
- Direct Marketing DI
- 16975586210055
- EMDN Code
- Z11069005 Diagnostic imaging workstations
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000049797
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Shenzhen Sunmc Dental Technology Co., Ltd.
Properties
Show properties
Other properties (13)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No