FEI 3007303685
Osteopore International Pte Ltd
2 Tukang Innovation Grove, #09-06 JTC MedTech Hub, Singapore South West, SG
MDR events5All time
Recalls1All time
Registered products1
Establishment typeManufactureManufacture Medical Device
Registered product codes
1 product codes
Recent MDR events
5 on file
Compliance history
Matched by FEI 3007303685.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Sep 26, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Sep 26, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.50(a)(1)Sep 26, 2024
Report of Death or Serious Injury
- 21 CFR 820.30(j)Sep 26, 2024
Design history file
- 21 CFR 820.90(a)Sep 26, 2024
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.