FEI 3010365473
Microtec Sas
41 rue dAyous, Serres Castet Pyrenees-Atlantiques, FR
MDR events0All time
Recalls0All time
Registered products7
Establishment typeManufactureManufacture Medical Device
Registered product codes
7 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 3010365473.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jun 5, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jun 5, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.70(i)Jun 5, 2025
Software validation for automated processes
- 21 CFR 820.75(c)Jun 5, 2025
Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Jun 5, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jun 5, 2025
Lack of or inadequate complaint 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.