Hidrex Gmbh
Otto-Hahn-Str. 12, Heiligenhaus North Rhine-Westphalia, DE
Registered product codes
1 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
3 on file
- TerminatedFeb 22, 2017
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
View FDA record ↗ - TerminatedFeb 22, 2017
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
View FDA record ↗ - TerminatedFeb 22, 2017
The device was reclassified from a class III device to a class II device and there are new documentation requirements.
View FDA record ↗
Compliance history
Matched by FEI 3008642982.
FDA inspections
2 on file
- Official Action Indicated (OAI)Nov 9, 2023
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Nov 9, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17Nov 9, 2023
Lack of Written MDR Procedures
- 21 CFR 820.198(c)Nov 9, 2023
Investigation of device failures
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.