BETA
Device group combining biodegradable stents, vascular devices and manufacturing capabilities across operating subsidiaries.
Q3 Medical Group is an Ireland-based medical-device holding and operating group led by Eric Mangiardi. Its group page identifies businesses including Q3 Medical Germany, AMG International, Q-San China and Q3 Medical USA, with development and manufacturing activities across several jurisdictions.
This is a group-level profile. ARCHIMEDES biodegradable stents and vascular-device families are attributed to their relevant operating entities, rather than creating duplicate parent and subsidiary company profiles. FDA’s pancreatic-stent record specifically names Q3 Medical USA, LLC, care of Q3 Medical Devices Ltd.
Commercial status is product- and country-specific. The U.S. pancreatic-stent clearance is documented separately from European biliary/pancreatic offerings and broader development programs. Older group-page statements about planned U.S. studies are not used to override a later FDA clearance or establish current availability of every group product.
Q3’s ARCHIMEDES pancreatic-stent program has FDA 510(k) decisions K243412 and K260835. The group’s biliary/bioresorbable development and vascular subsidiaries have separate regulatory scopes. Qualimed Srl contact-lens records belong to a different business and are excluded. [15][12][10][3][4][11][13][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [8][6]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
U.S. FDA applicant: Q3 Medical USA, LLC (c/o Q3 Medical Devices Ltd.); not a generic authorization for all group stents. [12][10]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Group-described biliary and pancreatic families with market-specific regulatory status. [12]
Marketed · regulatory scope variesCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Group profile with subsidiary-specific regulatory attribution. Pancreatic clearance is not generalized to biliary devices or the group’s vascular portfolio. [15][12][10]
FDA cleared the ARCHIMEDES pancreatic device under the Q3 Medical USA applicant; biliary products are not included by inference. [10]
Accessed 10/20/2026