Regulatory Clearances & Certifications

FDA Clearances (United States)

Glucology® products granted FDA clearance for US distribution:

Glucochews are manufactured in an FDA-approved facility – pharmaceutical-grade quality.

ARTG NUMBERS (Australia)

All medical devices are TGA-registered with the Therapeutic Goods Administration:

Australia's highest standards of safety, quality, and performance.

CE Mark (European Union & UK)

Many Glucology® products carry the CE Mark ( EU MDR CLASS I classification), demonstrating compliance with essential health, safety, and performance requirements across Europe and CE-recognising regions worldwide.

Global Certifications

In addition to FDA, CE approvals and ARTG numbers, many products hold further international certifications and test reports. Certificates available on request for healthcare professionals and partners.

Our Commitment

Every step of our design, testing, and manufacturing is guided by our mission to ease the burden of managing diabetes.

These clearances give our community confidence that every Glucology® product is safe, reliable, and backed by science.