Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Biolinq Incorporated
Free shipping on orders over $99 · 30-day returns
Biolinq Shine Autonomous Time-in-Range Microsensor is an FDA 510(k)-cleared medical device (DEN240080) manufactured by Biolinq Incorporated. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 22, 2025. Regulation: 8.