Self-expandable peripheral stent system - India CDSCO Medical Device Registration

Self-expandable peripheral stent system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000110_729ef0e0d428e810ff877fe8180cdeca_736b4076db6ccde55af1544e7c9bb6f9. This device is marketed under the brand name Zephyr , Rejuvant. The license holder is Sahajanand Laser Technology Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Self-expandable peripheral stent system

UID: MFG/MD/2019/000110_729ef0e0d428e810ff877fe8180cdeca_736b4076db6ccde55af1544e7c9bb6f9

Brand Name

Zephyr , Rejuvant

License Holder

Sahajanand Laser Technology Limited

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The Self-expandable peripheral stent system is indicated in treatment of patients with symptomatic de novo or restenotic native lesions or occlusion of the superficial femoral artery and/or proximal popliteal artery and for peripheral vascular use following failed percutaneous transluminal angioplasty (Zephyr , Rejuvant). It is also indicated for palliative treatment of biliary strictures produced by malignant neoplasm.