FEI 3004987887
Uscom Limited
LEVEL 8, SYDNEY New South Wales, AU
MDR events0All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device
Registered product codes
4 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 3004987887.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 29, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)May 29, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.22May 29, 2025
Quality audits - auditor independence
- 21 CFR 820.90(b)(2)May 29, 2025
Product rework documentation, DHR {see also 820.184}
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.