Sirolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration
Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000236_dd9e936185c45bb38483da5470752fd4_8f64502f902f919eb16a8f63ff6480a0. This device is marketed under the brand name EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL. The license holder is Nano Therapeutics Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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Brand Name
EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL
License Holder
Nano Therapeutics Pvt. Ltd.Device Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
Sirolimus Eluting Coronary Stent System (EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL) is intended for use in the patient eligible for Percutaneous Transluminal Coronary Angioplasty (EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL). Sirolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions and in-stent restenotic lesion of length ห52 mm in native coronary arteries with a reference vessel diameter of 2.00 to 4.50 mm
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