Balloon Expandable Coronary Stent System (“eucaLimus” - Balloon Expandable Coronary Stent System - Sirolimus Eluting Stent ) - India CDSCO Medical Device Registration

Balloon Expandable Coronary Stent System (“eucaLimus” - Balloon Expandable Coronary Stent System - Sirolimus Eluting Stent ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000295_f413c032b1832862e33a45082ebfe6e0_423597cbfaa35ca9056a2062feb51826. This device is marketed under the brand name Non-Sterile. The license holder is M/s Vascular Concepts Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Balloon Expandable Coronary Stent System (“eucaLimus” - Balloon Expandable Coronary Stent System - Sirolimus Eluting Stent )

UID: IMP/MD/2021/000295_f413c032b1832862e33a45082ebfe6e0_423597cbfaa35ca9056a2062feb51826

Brand Name

Non-Sterile

License Holder

M/s Vascular Concepts Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Eucalimus coronary stent system is a drug-coated coronary stent system, indicated for use in patients with symptomatic ischaemic coronary heart disease due to de novo lesions or re-stenosised lesions of the coronary arteries. The stent systems are also indicated for the treatment of acute or suspected occlusions in patients who responded unsuccessfully to an interventional therapy following balloon dilatation. The Eucalimus stent is intended for use in patients eligible for PTCA with a reference vessel diameter of 2.25mm to 4.00mm (Non-Sterile) and is intended to expand the lumen of the coronary arteries as well as maintaining the vessel patency. The lesion to be treated should be shorter than the nominal length of the stent at a reference vessel diameter of 2.25mm to 4.00mm