Drug Eluting Coronary Stent System - India CDSCO Medical Device Registration
Drug Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000073_6a11d97158630de4cf3efb410f3c818b_26976c235ac441031254d3fab10c57b0. This device is marketed under the brand name BioFreedom. The license holder is Dr. Remedies Life Sciences Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
BioFreedom
License Holder
Dr. Remedies Life Sciences Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The BioMatrix NeoFlex DES is indicated for improving coronary luminal diameter for the treatment of de novo lesions in native coronary arteries with a reference diameter ranging between 2.25 mm and 4.0 mm. The Stent Length (BioFreedom): 8, 11, 14, 18, 24, 28, 33*, 36*,42,48 are available. The Stents with length 33 mm and 36 mm are only available for artery diameters ranging between 2.5 mm and 3.5 mm. The BioMatrix NeoFlex DES with stent length up to 28 mm is also indicated for use in patients with: • ST elevated myocardial infarction (BioFreedom) • Acute Coronary Syndromes (BioFreedom) including ACS-STEMI, ACS-NSTEMI and Unstable Angina • Diabetes Mellitus
Drug Coated Coronary Stent System
Brand: BioFreedom
Cardiologix
Drug Eluting Coronary Stent System
Brand: BioFreedom
Cardiologix
Drug Eluting Coronary Stent System
Brand: BioMatrix NeoFlex
Biosensors Medical India Pvt. Ltd.
Drug Eluting Coronary Stent System
Brand: BioMatrix NeoFlex
Biosensors Medical India Pvt. Ltd.
Drug Coated Coronary Stent System
Brand: BioFreedom
T. A. Technologies And Healthcare
Drug Eluting Coronary Stent System
Brand: BioFreedom
T. A. Technologies And Healthcare
Drug Eluting Coronary Stent System
Brand: BioFreedom
T. A. Technologies And Healthcare
Drug Eluting Coronary Stent System
Brand: BioMatrix Alpha
Curis Healthcare
Drug Eluting Coronary Stent System
Brand: BioMatrix Alpha
Curis Healthcare
Drug Coated Coronary Stent System
Brand: BioFreedom
Dr. Remedies Life Sciences Pvt. Ltd.