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/2019/000159_d54e4aab53783a99ea3989a3d6573296_c4b3026abf6ddc764cdec6a5e73d0107. This device is marketed under the brand name Sirolimus. The license holder is 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/2019/000159_d54e4aab53783a99ea3989a3d6573296_c4b3026abf6ddc764cdec6a5e73d0107

Brand Name

Sirolimus

License Holder

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 a delivery 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

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Class C

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Brand: Steer-R

Class C