FEI 3011648943
Healcerion Co., Ltd
1013-Ho, 12 Digital-Ro 33-Gil, Guro-Gu, Seoul, KR
MDR events0All time
Recalls0All time
Registered products3
Establishment typeManufactureManufacture Medical Device
Registered product codes
3 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 3011648943.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Mar 7, 2025
Compliance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.22Mar 7, 2025
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.80(a)Mar 7, 2025
Lack of or inadequate procedures - Acceptance activities
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.