Magnamed Tecnologia Medica S/a
Rua Maquerobi, 140, Sao Paulo, BR
Registered product codes
3 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 3024290085.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 10, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Apr 10, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗21 CFR 801.20(a)Label to bear a unique device identifier
121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.75(a)Lack of or inadequate process validation
121 CFR 820.184Lack of or inadequate DHR procedures
1
- 21 CFR 801.20(a)Apr 10, 2025
Label to bear a unique device identifier
- 21 CFR 820.30(g)Apr 10, 2025
Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(i)Apr 10, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Apr 10, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Apr 10, 2025
Lack of or inadequate process validation
- 21 CFR 820.184Apr 10, 2025
Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Apr 10, 2025
Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Apr 10, 2025
Sampling plans
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.