Stent Graft System - India CDSCO Medical Device Registration

Stent Graft System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000451_4e1501c99ce27b28129b025c3e7fdcf9_b105f79bc28d7efd67a52de9a88ee8eb. This device is marketed under the brand name E-vita Thoracic 3G. The license holder is Vibgyor Health Care 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

Stent Graft System

UID: IMP/MD/2019/000451_4e1501c99ce27b28129b025c3e7fdcf9_b105f79bc28d7efd67a52de9a88ee8eb

Brand Name

E-vita Thoracic 3G

License Holder

Vibgyor Health Care Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

E-vita OPEN NEO is indicated for the surgical treatment of patients with dissections or aneurysms having the following characteristics: • Acute or chronic aortic dissection, DeBakey type I • Acute or chronic aortic dissection, DeBakey type III, with retrograde progression in the aortic arch; with or without involvement of the ascending aorta • Thoracic aortic aneurysm involving the descending thoracic aorta and the aortic arch; with or without involvement of the ascending aorta

Class D

Brand: E-vita Thoracic 3G

Class D