Kenex (electro-medical) Ltd.
Unit 17, RO24 Greenway, HARLOW Essex, GB
Registered product codes
7 product codes
Recent MDR events
1 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1000396729.
FDA inspections
2 on file
- Official Action Indicated (OAI)Mar 14, 2024
Postmarket Assurance: Devices · Citations posted
- Official Action Indicated (OAI)Mar 14, 2024
Compliance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17Lack of Written MDR Procedures
121 CFR 820.30(a)Design control - no procedures
121 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
121 CFR 820.80(d)Lack of or inadequate final acceptance procedures
121 CFR 820.120Lack of or inadequate procedures for labeling
121 CFR 820.198(a)Lack of or inadequate complaint procedures
1
- 21 CFR 803.17Mar 14, 2024
Lack of Written MDR Procedures
- 21 CFR 820.30(a)Mar 14, 2024
Design control - no procedures
- 21 CFR 820.70(a)Mar 14, 2024
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.80(d)Mar 14, 2024
Lack of or inadequate final acceptance procedures
- 21 CFR 820.120Mar 14, 2024
Lack of or inadequate procedures for labeling
- 21 CFR 820.198(a)Mar 14, 2024
Lack of or inadequate complaint procedures
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.