Certificates
In addition to developing products that meet the stringent specifications of our customers, our registrations and certifications allow us to manufacture medical device components and assemblies in compliance with a wide range of regulatory bodies.
Note: FMI, LLC and Medron, LLC are wholly owned subsidiaries of Flexan, LLC.
Flexan Lincolnshire ISO 13485:2016
FDA Registration Numbers:
3014507028
Flexan Salt Lake City ISO 13485:2016
FDA Registration Numbers:
1722746
3013446345
Flexan Suzhou ISO 13485:2016
FDA Registration Number:
3007285848
Flexan Juarez ISO 13485:2016
FDA Registration Number: GSC13485MX115