Regulatory Clearances & Certifications

At Glucology, trust, safety, and quality aren’t optional—they’re our standard. Every product is designed with rigorous testing, regulatory compliance, and global standards in mind so you can manage diabetes with confidence.

US Regulatory Compliance

FDA Clearances (United States) These Glucology products are cleared for distribution in the U.S.:

• Sharps Containers – safe, compliant disposal on the go or at home
• Insulin Cooling Bags – independently tested to keep meds protected and cool
• CGM Patches – hypoallergenic, skin‑friendly adhesion for secure wear
• Insulin Pump Belts – comfortable, secure support for daily pump use
• Diacare Copper Socks – diabetic-friendly design to help protect sensitive feet

Plus, Glucochews are manufactured in an FDA-registered facility for consistent, high-quality production.

International Standards We Meet

TGA (Australia) Registered with Australia’s Therapeutic Goods Administration (TGA), including:

• Lancets
• Lancing Devices
• Glucology Skin Cleaning Wipes
• Blood Glucose Monitors
• Blood Glucose Test Strips

CE Mark (European Union & United Kingdom) Many Glucology products carry the CE Mark, demonstrating compliance with EU/UK health, safety, and performance requirements.

Global Certifications Across our range, you’ll find additional international certifications and test reports that validate safety and performance. Certificates are available on request for healthcare professionals and partners.

Our Promise From design through manufacturing, our mission is to make diabetes management easier, safer, and less stressful. With recognized clearances and certifications behind every product, Glucology delivers reliability you can feel—and results you can trust.

Need documentation or have clinical questions? Contact us and we’ll share certificates, testing data, and product details tailored to your needs.