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Balloon Expandable Cobalt Chromium Peripheral Stent System - India CDSCO Medical Device Registration

Balloon Expandable Cobalt Chromium Peripheral Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000236_ab77a2c2339a2e7199bada4eb33bad1e_fcdf04a8b7c1a5f5933810e58f492d7a. 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.

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CDSCO Registered
Class Class D
Balloon Expandable Cobalt Chromium Peripheral Stent System
UID: MFG/MD/2020/000236_ab77a2c2339a2e7199bada4eb33bad1e_fcdf04a8b7c1a5f5933810e58f492d7a

Brand Name

EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Balloon Expandable Cobalt Chromium Peripheral Stent System is indicated for improving luminal diameter of lower limbs arteries (EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL) in patients with de novo and restenotic lesions, with reference vessel diameters between 4.00 mm to 12.00 mm and lesion lengths up to 199 mm. The stent is intended as a permanent implant.

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