Intraoral Scanner
by Foshan Vimel Dental Equipment CO., LTD. EUDAMED
Active
Ref VI 5.0 Pro, VI 6.0 Pro, VI 3.0 ProModel VI 3.0 Pro, VI 5.0 Pro ,VI 6.0 Pro
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697808746ScannerDA | Date30 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Intraoral Scanner
- Model / Reference
- VI 3.0 Pro, VI 5.0 Pro, VI 6.0 Pro
- Primary DI / UDI-DI
- 06978087460014, 06978087460021, 06978087460007
- Basic UDI-DI
- 697808746ScannerDA
- EMDN Code
- Z11030402 Systems for intraoral digital videoradiography
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000048412
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Foshan Vimel Dental Equipment CO., LTD.
See all devices from Foshan Vimel Dental Equipment CO., LTD. →
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