Registrations

Biomerics is registered with the FDA and maintains ISO 13485 certification. These registrations and certifications allow us to manufacture medical devices in compliance with FDA requirements, CE Mark requirements, and other medical device governing body requirements throughout the world.

Biomerics has Registrations in both Domestic and International Regions including:

  • Australia
  • Japan
  • South Korea
  • Brazil
  • Mexico
  • Argintina
  • European Union

ISO 13485 Certified

Biomerics - Salt Lake City, UT ISO 13485 Certificate Download Download
Biomerics Advanced Catheter - Brooklyn Park, MN ISO 13485 Certificate Download Download
Biomerics FMI - Athens, TX ISO 13485 Certificate Download Download
Biomerics NLE - Monroe, CT ISO 13485 Certificate Download Download
Biomerics CRI - Indianapolis, IN ISO 13485 Certificate Download Download
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