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Regulatory Registrations & Certifications

At IBD Medical, trust, safety, and quality are essential for diabetes management. Our Glucology® products are listed or registered with the relevant regulators in the markets we sell to.

✅ FDA LISTED

FDA Listed (United States)

Glucology® products are FDA-listed for US distribution:

  • Sharp Bin Containers – safe sharps disposal
  • Insulin Cooling Bags – reliable medicine protection
  • CGM Patches – hypoallergenic, skin-safe adhesion
  • Insulin Pump Belts – FDA-listed (Class I), secure pump wear
  • Diacare Socks – FDA-listed (Class I), copper-infused socks

Glucochews are manufactured in an FDA-registered facility.

✅ ARTG Included

ARTG NUMBERS (Australia)

The following Glucology® medical devices are included in the Australian Register of Therapeutic Goods (ARTG):

  • Lancets – ARTG 297476
  • Lancing Device – ARTG 337171
  • CGM Patches (Sensor Shields) – ARTG 522859 & 530265
  • Glucology Skin Cleaning Wipes – ARTG 447925

You can search any ARTG number on the TGA website to view the entry.

✅ CE Mark

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 Standards

Global Certifications

In addition to FDA listings, CE marking and ARTG numbers, many products hold further international certifications and test reports. Certificates are 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 listings and registrations are part of how we hold every Glucology® product to a high standard.

Certified Quality Assurance

FDA-listed and CE-marked diabetes accessories from Sydney Ultimo
Serving 350K+ customers & 1,400+ pharmacies, including Terry White Chemist (TWCM), Chemist Warehouse (CWH) and many local pharmacies.

🛒 Shop Our Range → 📄 Request Certificates

📍 31/330 Wattle Street, Ultimo NSW 2007 | 1-Day Dispatch | Free Shipping >$120

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