FEI 3012606445
Linxens Sweden Ab
Brandsvigsgatan 11A, Angelholm Skane, SE
MDR events0All time
Recalls0All time
Registered products6
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
6 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 3012606445.
FDA inspections
2 on file
- No Action Indicated (NAI)Nov 7, 2024
Postmarket Assurance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Nov 7, 2024
Compliance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.75(a)Nov 7, 2024
Documentation
- 21 CFR 820.30(h)Nov 7, 2024
Design transfer - Lack of or inadequate procedures
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.