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Paclitaxel Coated Balloon Catheter - India CDSCO Medical Device Registration

Paclitaxel Coated Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000236_bbbb947099514904ac6dff6339d802e0_3dca6d1fd3548aeb86c0eeaee8cdc8d9. This device is marketed under the brand name EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL. The license holder is Nano Therapeutics Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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.

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CDSCO Registered
Class Class D
Paclitaxel Coated Balloon Catheter
UID: MFG/MD/2020/000236_bbbb947099514904ac6dff6339d802e0_3dca6d1fd3548aeb86c0eeaee8cdc8d9

Brand Name

EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Paclitaxel Coated PTCA balloon catheter is intended for treatment of atherosclerotic depositions in coronary lesions, specifically in patients with either in-stent restenosis or de novo coronary lesions with a reference vessel diameter ranging from 1.50 mm to 4.50 mm and lesion lengths up to 41 mm and it is also intended for pre and post dilatation during coronary stent implantation for improving luminal diameter. Paclitaxel Coated PTA balloon catheter is intended for treatment of atherosclerotic depositions in peripheral lesions, specifically in patients with either in-stent restenosis or de novo peripheral lesions with a reference vessel diameter ranging from 2.00 mm to 12.00 mm and lesion lengths up to 200 mm and it is also intended for pre and post dilatation during peripheral stent implantation for improving luminal diameter

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