FEI 3005545216
Tonica Elektronik A/s
LUCERNEMARKEN 15, FARUM Hovedstaden, DK
MDR events5All time
Recalls0All time
Registered products6
Establishment typeManufactureManufacture Medical Device
Registered product codes
6 product codes
Recent MDR events
5 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3005545216.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 27, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Mar 27, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(g)Mar 27, 2025
Design validation - user needs and intended uses
- 21 CFR 820.184Mar 27, 2025
DHR content
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.