Drug Eluting Stent - India CDSCO Medical Device Registration

Drug Eluting Stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000591_02c065524b5d157cdf1cefa54280210d_4c69ff9797edce60a34dea523d539661. This device is marketed under the brand name Sirolimus. The license holder is CARDIOAXIS CORPORATION PVT LTD C/O FRISCH MEDICAL DEVICES PVT LTD, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class D

Drug Eluting Stent

UID: MFG/MD/2023/000591_02c065524b5d157cdf1cefa54280210d_4c69ff9797edce60a34dea523d539661

Brand Name

Sirolimus

License Holder

CARDIOAXIS CORPORATION PVT LTD C/O FRISCH MEDICAL DEVICES PVT LTD

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

Stent, coronary, drug-eluting - a metal scaffold with a drug coating placed via adelivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.

Class D

Drug Eluting Stent

Brand: Sirolimus

FRISCH MEDICAL DEVICES PVT. LTD.

Class D

Other Products from CARDIOAXIS CORPORATION PVT LTD C/O FRISCH MEDICAL DEVICES PVT LTD

Products from the same license holder (1 products)

Drug Coated dilation catheter

Brand: Sirolimus

Class D