SkinVision
Model 6.0
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number872089231SV6.0G5 | Date14 Dec 2023 | StatusActive |
| European Union | CE/MDR | Number872089231SV6.0G5 | Date14 Dec 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Device Name
- SkinVision Service
- Model / Reference
- 6.0
- Primary DI / UDI-DI
- 08720892314703, D-NL-MF-0000060526Y
- Basic UDI-DI
- 872089231SV6.0G5, B-NL-MF-0000060526Y
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class IIaClass I
- Special Device Type
- Software-1192
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000006052
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