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/2020/000472_2d4f3fa0e5e4db6adf50e31497e27333_38540d417f8d22ff65feb3ca5121ddce. This device is marketed under the brand name Ultraskin. The license holder is M/s LepuCare (India) Vascular Solutions Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Sirolimus-Eluting Coronary Stent System

UID: IMP/MD/2020/000472_2d4f3fa0e5e4db6adf50e31497e27333_38540d417f8d22ff65feb3ca5121ddce

Brand Name

Ultraskin

License Holder

M/s LepuCare (India) Vascular Solutions Pvt. Ltd.,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The PARTNER® Stent is indicated for use in: • Patients eligible for balloon angioplasty with symptomatic ischemic heart disease due to discrete de novo and/or restenotic native coronary artery lesions with reference vessel diameters ranging from 2.5 mm to 4.0 mm, and with target vessel stenosis degree more than 70% , or having evident ischemic symptom and target lesion stenosis degree more than 50%. • Patients with acute occlusion or on the verge of occlusion during percutaneous coronary intervention. • Patients with significant residual stenosis after simple balloon dilatation • Patients with acute coronary syndromes

Class D

Hydrophilic Guidewire

Brand: Ultraskin

M/s LepuCare (India) Vascular Solutions Pvt. Ltd.,

Class D

Brand: Ultraskin

Class D