cGMP / FDA Approved No. 3003334541

Concise Enterprises is an FDA-approved medical device manufacturer, maintaining registration with the U.S. Food and Drug Administration (FDA) since 2001. This approval reflects the company’s full compliance with the Current Good Manufacturing Practices (cGMP) requirements outlined in 21 CFR Part 820, which govern the quality system regulations for medical device manufacturers.

Under these regulations, Concise Enterprises ensures that every stage of production from raw material inspection to final product packaging meets the highest international standards of quality, safety, and traceability. The company’s FDA registration and adherence to cGMP demonstrate its ongoing commitment to delivering safe, reliable, and high-performance surgical and dental instruments to healthcare professionals worldwide.

This recognition further strengthens Concise Enterprises’ global credibility and supports its continuous efforts to expand its presence in regulated markets, including the United States, European Union, and other international regions.

Exhibitor Data Sheet