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CDSCO UID IMP/MD/2020/000166_95a1678a882ce75f273e1b9a5a4f4e1a_ee4d6b6d73d6c216473a304fc3dccbdf

Sirolimus eluting coronary stent system, with CoCr Stent and permanent polymer

M/s. Luminor Medical Devices Pvt. Ltd. ,Unit No. EPO-03-007, 3rd Floor, Emaar Emerald Plaza, Sector 65, Gurugram ,Gurgaon Haryana ,122018 ,India·Device Class Class D·India CDSCO·Brand: iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35
Registration details
UID
IMP/MD/2020/000166_95a1678a882ce75f273e1b9a5a4f4e1a_ee4d6b6d73d6c216473a304fc3dccbdf
Device class
Class D
Brand name
iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35
License holder
M/s. Luminor Medical Devices Pvt. Ltd. ,Unit No. EPO-03-007, 3rd Floor, Emaar Emerald Plaza, Sector 65, Gurugram ,Gurgaon Haryana ,122018 ,India
Approving authority
CDSCO
Product information
The device is indicated for increasing the internal diameter of an artery with the aim of improving blood flow in the following cases: • Patients with symptomatic ischemic heart disease due to “de novo” stenotic and re-stenotic lesions located in arteries with diameters from 2mm to 4.5mm. • Patients with occlusive disease due to acute myocardial infarction located in arteries with diameters from 2mm to 4.5mm
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About this record

Sirolimus eluting coronary stent system, with CoCr Stent and permanent polymer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000166_95a1678a882ce75f273e1b9a5a4f4e1a_ee4d6b6d73d6c216473a304fc3dccbdf. This device is marketed under the brand name iVascular luminor 14m, iVascular luminor 18, iVascular luminor 35. The license holder is M/s. Luminor Medical Devices Pvt. Ltd. ,Unit No. EPO-03-007, 3rd Floor, Emaar Emerald Plaza, Sector 65, Gurugram ,Gurgaon Haryana ,122018 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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