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Versatile Atrial Septal Occluder Device - India CDSCO Medical Device Registration

Versatile Atrial Septal Occluder Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000236_a067e8ed6486bfdb2b9cc120a425e8cb_f1d754bdc6e2b07f5b905ea2621a05a7. 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
Versatile Atrial Septal Occluder Device
UID: MFG/MD/2020/000236_a067e8ed6486bfdb2b9cc120a425e8cb_f1d754bdc6e2b07f5b905ea2621a05a7

Brand Name

EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The Versatile Atrial Septal Occluder Device (EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL) is indicated for the occlusion of atrial septal defects (EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL) in secundum position. The device is also indicated in patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration. Patients indicated for Septal Defect Occluder closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (EnCruso RAL, EverMax RAL, Cruzon RAL, EverLite RAL)

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