FEI 3010668881
Gunze Limited
46 Natsumegaichi, Aono, Ayabe Kyoto, JP
MDR events20All time
Recalls0All time
Registered products2
Establishment typeManufactureManufacture Medical Device
Registered product codes
2 product codes
Recent MDR events
20 on file
- NEOVEILMay 31, 2026Injury3012602431-2026-00046
- NEOVEILMay 31, 2026Injury3012602431-2026-00051
- NEOVEIL (SHEET)Apr 30, 2026Injury3010668881-2026-00003
- NEOVEILMar 26, 2026Injury3010668881-2026-00002
- NEOVEILMar 16, 2026Injury3010668881-2026-00001
- NEOVEIL (SHEET)Jan 26, 2026Injury3012602431-2026-00009
- NEOVEIL (SHEET)Jan 26, 2026Injury3012602431-2026-00010
- NEOVEIL (SHEET)Jan 26, 2026Malfunction3012602431-2026-00011
- NEOVEIL(SHEET)Dec 23, 2025Injury3010668881-2025-00004
- NEOVEIL(SHEET)Dec 23, 2025Injury3010668881-2025-00005
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3010668881.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jun 12, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jun 12, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.22Jun 12, 2025
Quality audits - auditor independence
- 21 CFR 820.25(b)Jun 12, 2025
Training records
- 21 CFR 820.90(a)Jun 12, 2025
Nonconforming product control
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.