CoCr Sirolimus-eluting Coronary Stent System - India CDSCO Medical Device Registration

CoCr 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_6cea38a486394e3a2ed0c96d2c216ced_54df1f63c9636651c1709d6d87042328. 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

CoCr Sirolimus-eluting Coronary Stent System

UID: IMP/MD/2020/000472_6cea38a486394e3a2ed0c96d2c216ced_54df1f63c9636651c1709d6d87042328

Brand Name

Ultraskin

License Holder

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

Device Class

Class D

Approving Authority

CDSCO

Product Information

GuReater™ CoCr Sirolimus-eluting Coronary Stent system are indicated for improving coronary luminal diameter in the following: • Patients with symptomatic ischemic heart disease due to de novo native coronary artery lesions (Ultraskin) with reference vessel diameters ranging from 2.25 mm to 4.5 mm; • Patients with restoring acute coronary occlusion or endangered coronary occlusion during percutaneous coronary intervention; • Patients with acute coronary artery syndrome (Ultraskin) relevant lesions; • Patients with vascular dissection and/or laceration

Class D

Hydrophilic Guidewire

Brand: Ultraskin

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

Class D

Brand: Ultraskin

Class D