Aneurysm Embolization System - India CDSCO Medical Device Registration

Aneurysm Embolization System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000108_19cd91cfc24e0127fef7ebad64d51371_6d3218e030cc5af7476a8a1de93c8e28. This device is marketed under the brand name SOFIA EX. The license holder is Faith Biotech 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

Aneurysm Embolization System

UID: IMP/MD/2021/000108_19cd91cfc24e0127fef7ebad64d51371_6d3218e030cc5af7476a8a1de93c8e28

Brand Name

SOFIA EX

License Holder

Faith Biotech Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The WEB Aneurysm Embolization System is intended for the endovascular embolization of ruptured and unruptured intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae (SOFIA EX). The WEB Aneurysm Embolization System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation

Class C

Aneurysm Embolization System

Brand: WEB Aneurysm Embolization System

Faith Biotech Pvt. Ltd.

Class D

Brand: Flow Re-Direction Endoluminal Device

Class D