Polymer-free Sirolimus-eluting Coronary Stent System - India CDSCO Medical Device Registration

Polymer-free 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_55758c2c5fb023ac26a00028f17670bd_5c10bd524e28ecde5f1f121d79443804. 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

Polymer-free Sirolimus-eluting Coronary Stent System

UID: IMP/MD/2020/000472_55758c2c5fb023ac26a00028f17670bd_5c10bd524e28ecde5f1f121d79443804

Brand Name

Ultraskin

License Holder

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

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Nano+ stent system is indicated for use in: • Patients with localized stenosis lesions whose reference vessel diameters are larger than 2.25 mm and need stenting to prevent restenosis. • Patients with vascular dissection and (Ultraskin) tear. • Patients with restenosis after simple balloon dilatation. • Patients with acute vascular occlusion and close to vascular occlusion within coronary intervention surgery.

Class D

Hydrophilic Guidewire

Brand: Ultraskin

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

Class D

Brand: Ultraskin

Class D