FEI 3015497424
Unimax Medical Systems Inc.
No. 37, Sec. 2, Ligong 1st Rd., Wujie Township, Yilan County, TW
MDR events200All time
Recalls1All time
Registered products13
Establishment typeManufactureManufacture Medical Device
Registered product codes
13 product codes
Recent MDR events
200 on file
- DETACHABLE ENDO POCKETJul 8, 2026Malfunction3007791595-2026-00008
- DETACHABLE ENDO POCKETJun 30, 2026Malfunction3007791595-2026-00006
- DETACHABLE ENDO POCKETJun 30, 2026Malfunction3007791595-2026-00007
- DETACHABLE ENDO POCKETJun 21, 2026Malfunction3007791595-2026-00004
- DETACHABLE ENDO POCKETJun 21, 2026Malfunction3007791595-2026-00005
- DETACHABLE ENDO POCKETJun 10, 2026Malfunction3007791595-2026-00003
- DETACHABLE ENDO POCKETMar 31, 2026Malfunction3007791595-2026-00002
- DETACHABLE ENDO POCKETMar 20, 2026Malfunction3007791595-2026-00001
- DETACHABLE ENDO POCKETMar 6, 2026Malfunction3007791595-2025-00018
- DETACHABLE ENDO POCKETFeb 26, 2026Malfunction3007791595-2025-00017
Compliance history
Matched by FEI 3015497424.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 6, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Mar 6, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17Mar 6, 2025
Lack of Written MDR Procedures
- 21 CFR 803.50(a)(2)Mar 6, 2025
Individual Report of Malfunction
- 21 CFR 820.70(c)Mar 6, 2025
Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(b)(2)Mar 6, 2025
Documentation of validated process performance
- 21 CFR 820.198(a)Mar 6, 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.