FEI 1181055
Hemagen Diagnostics, Inc.
2900 LOCH RAVEN RD, Baltimore, MD, US
MDR events0All time
Recalls0All time
Registered products43
Establishment typeManufactureManufacture Medical Device
Registered product codes
43 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 1181055.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 14, 2026
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)May 14, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- ISO 13485:2016 Clause 4.2.5May 14, 2026
Procedures for control of records not documented
- ISO 13485:2016 Clause 7.4.1May 14, 2026
Supplier performance not monitored
- ISO 13485:2016 Clause 8.5.2May 14, 2026
Corrective action not taken
- ISO 13485:2016 Clause 8.5.2May 14, 2026
Corrective action procedures not documented
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.