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 IMP/MD/2020/000218_6c9c8e674ee317712f8dd72da8ce69bc_ee4d6b6d73d6c216473a304fc3dccbdf. This device is marketed under the brand name CoCr Stent and permanent polymer. The license holder is Raymed Trading Group Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
CoCr Stent and permanent polymer
License Holder
Raymed Trading Group Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The device is indicated for increasing the internal diameter of an artery with the aim of improving blood flow in the following cases: • Patients with symptomatic ischemic heart disease due to “de novo” stenotic and re-stenotic lesions located in arteries with diameters from 2mm to 4.5mm. • Patients with occlusive disease due to acute myocardial infarction located in arteries with diameters from 2mm to 4.5mm
