CDSCO UID IMP/MD/2021/000728_d3f48960dfa9a210fb2a16c83b1a0c88_8e398157af239e2dfdbdf37182b69458

Drug Coated Coronary Stent System

Curis Healthcare·Device Class Class D·India CDSCO·Brand: BioMatrix Alpha
Registration details
UID
IMP/MD/2021/000728_d3f48960dfa9a210fb2a16c83b1a0c88_8e398157af239e2dfdbdf37182b69458
Device class
Class D
Brand name
BioMatrix Alpha
License holder
Curis Healthcare
Approving authority
CDSCO
Product information
The BioFreedom DCS is indicated for improving coronary luminal diameter for the treatment of de-novo lesions in native coronary arteries with a reference diameter ranging from 2.25 mm to 4.0 mm. Stents with lengths of 33 mm and 36 mm are only available for artery diameters ranging from 2.5 mm to 3.5 mm.
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About this record

Drug Coated Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000728_d3f48960dfa9a210fb2a16c83b1a0c88_8e398157af239e2dfdbdf37182b69458. This device is marketed under the brand name BioMatrix Alpha. The license holder is Curis Healthcare, and it is classified as Device Class Class D. The approving authority is CDSCO.

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