Coronary Stent Delivery System - India CDSCO Medical Device Registration

Coronary Stent Delivery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000472_0fedf497d64c8402c898cbdd916f6b52_7f26aca46bf968eaef9894e024c15233. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class D

Coronary Stent Delivery System

UID: IMP/MD/2020/000472_0fedf497d64c8402c898cbdd916f6b52_7f26aca46bf968eaef9894e024c15233

Brand Name

Ultraskin

License Holder

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

Device Class

Class D

Approving Authority

CDSCO

Product Information

H-Stent™ Coronary Stent Delivery System 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