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_463cd70c101fa66fec96cb7ebc9a7411. 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_463cd70c101fa66fec96cb7ebc9a7411

Brand Name

E-vita Thoracic 3G

License Holder

Vibgyor Health Care Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The E-vita thoracic 3G stent graft from JOTEC GmbH has been specially developed for treatment of aneurysms, dissections and specific lesions of the thoracic aorta descendens. The main indications for use of a stent graft from JOTEC GmbH would be, in particular, acutely life-threatening patient conditions due to • aneurysm rupture • traumatic aortic rupture • aortic dissection • a plaque rupture • a penetrating aortic ulcer (E-vita Thoracic 3G) • an intramural haematoma (E-vita Thoracic 3G) • an aortobronchial fistula or aortooesophageal fistula

Class D

Brand: E-vita Thoracic 3G

Class D