Tr Equipment Ab
RUNDELG 2, P.O. BOX 116, TRANAS Jonkoping, SE
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 3002913923.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 7, 2023
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Dec 7, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
9 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17Lack of Written MDR Procedures
121 CFR 820.30(e)Design review - Lack of or inadequate procedures
121 CFR 820.30(f)Design verification - Lack of or inadequate procedures
121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
121 CFR 820.40Procedures not adequately established or maintained
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
1
- 21 CFR 803.17Dec 7, 2023
Lack of Written MDR Procedures
- 21 CFR 820.30(e)Dec 7, 2023
Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Dec 7, 2023
Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Dec 7, 2023
Design validation- Lack of or inadequate procedures
- 21 CFR 820.40Dec 7, 2023
Procedures not adequately established or maintained
- 21 CFR 820.90(a)Dec 7, 2023
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Dec 7, 2023
Lack of or inadequate procedures
- 21 CFR 820.198(a)Dec 7, 2023
Complaints
- 21 CFR 830.300(a)Dec 7, 2023
Devices subject to device identification GUDID data submission requirements.
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.