FEI 3030089787
Gemss Healthcare Co., Ltd.
1F, 822, Bogwang-ro, Gwangtan-myeon, Paju-si, Gyeonggi, KR
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 3030089787.
FDA inspections
3 on file
- Voluntary Action Indicated (VAI)Feb 6, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 6, 2025
Postmarket Assurance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Feb 6, 2025
Radiation Control and Health Safety Act · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(i)Feb 6, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Feb 6, 2025
Lack of or inadequate final acceptance procedures
- 21 CFR 1010.2(c)Feb 6, 2025
Certification not based on adequate test/testing program
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.