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SIROLIMUS ELUTING CORONARY STENT SYSTEM - India CDSCO Medical Device Registration

SIROLIMUS ELUTING CORONARY STENT SYSTEM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000086_642da2b2caef3b713baf80577048593f_2ca0c6fa9c24a3258467f4af5778afb6. This device is marketed under the brand name TRICVALVE/ TREBLE/ TRICHOTOMIC/ TRIO/ TRICUSPIDEM. The license holder is Relisys Medical Devices Limited, and it is classified as Device Class Class D. The approving authority is CDSCO, Zonal office, Hyderabad.

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CDSCO Registered
Class Class D
SIROLIMUS ELUTING CORONARY STENT SYSTEM
UID: MFG/MD/2020/000086_642da2b2caef3b713baf80577048593f_2ca0c6fa9c24a3258467f4af5778afb6

Brand Name

TRICVALVE/ TREBLE/ TRICHOTOMIC/ TRIO/ TRICUSPIDEM

Device Class

Class D

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

The Relisys Sirolimus Eluting Coronary Stent System is indicated for improving luminal diameter and reducing restenosis for the treatment of de novo lesions in native coronary arteries. Sirolimus Eluting Coronary Stent System is also indicated for treatment of abrupt of threatened closure in patients with failed interventional therapy. The drug coating is intended to inhibit restenosis

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