FEI 3012992602
Toul Meditech Ab
Tunbytorpsgatan 31, Vasteras Vastmanland, SE
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 3012992602.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 27, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 27, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.70(a)Feb 27, 2025
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Feb 27, 2025
Lack of or inadequate process validation
- 21 CFR 820.184Feb 27, 2025
DHR content
- 21 CFR 820.198(a)Feb 27, 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.