FEI 3006621332
Ziosoft, Inc.
Mitakokusai Bldg., Minato-ku Tokyo, JP
MDR events2All time
Recalls0All time
Registered products3
Establishment typeManufactureManufacture Medical Device
Registered product codes
3 product codes
Recent MDR events
2 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3006621332.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 18, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Dec 18, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.50(a)(2)Dec 18, 2025
Individual Report of Malfunction
- 21 CFR 820.50Dec 18, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Dec 18, 2025
Lack of or inadequate process validation
- 21 CFR 820.198(a)Dec 18, 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.