FEI 1000268398
Levo Ag
ANGLIKERSTRASSE 20, WOHLEN Aargau, CH
MDR events0All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device
Registered product codes
1 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 1000268398.
FDA inspections
2 on file
- Official Action Indicated (OAI)Apr 9, 2025
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Apr 9, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17Apr 9, 2025
Lack of Written MDR Procedures
- 21 CFR 820.20(e)Apr 9, 2025
Quality System Procedures
- 21 CFR 820.25(a)Apr 9, 2025
Personnel
- 21 CFR 820.198(a)Apr 9, 2025
Lack of or inadequate complaint procedures
- 21 CFR 830.300(a)Apr 9, 2025
Devices subject to device identification GUDID data submission requirements.
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.