FEI 3010067148
Seriously Clean Ltd
1075 W Kathryn St Ste 6, Nixa, MO, US
MDR events0All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device
Registered product codes
1 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 3010067148.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 11, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Mar 11, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 801.20(a)Mar 11, 2026
Label to bear a unique device identifier
- ISO 13485:2016 Clause 7.4.1Mar 11, 2026
Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 7.6(a)Mar 11, 2026
Measuring equipment not adequately calibrated or verified
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.