FEI 3002807605
Mikasa X-ray Co., Ltd.
2-7-2 Shirotaecho, Minami-ku,, Yokohama-shi Kanagawa, JP
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 3002807605.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jun 5, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jun 5, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.40(b)Jun 5, 2025
Document change records, maintained.
- 21 CFR 820.100(b)Jun 5, 2025
Documentation
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.