FEI 3004531930
Ultrasun
GRANAATSTRAAT 6, HENGELO Overijssel, NL
MDR events0All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device
Registered product codes
4 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3004531930.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 11, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jul 11, 2024
Radiation Control and Health Safety Act · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.40Jul 11, 2024
Procedures not adequately established or maintained
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.