Drug Coated Dilation Catheter - India CDSCO Medical Device Registration

Drug Coated Dilation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000159_9b7326c59a7793eac9c729dc468a46f7_aa2cb9af4bc983f4d487c61ea56cc5f6. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class D

Drug Coated Dilation Catheter

UID: MFG/MD/2019/000159_9b7326c59a7793eac9c729dc468a46f7_aa2cb9af4bc983f4d487c61ea56cc5f6

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

It is intended for balloon dilation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion

Class D

Drug Eluting Stent

Brand: Sirolimus

FRISCH MEDICAL DEVICES PVT. LTD.

Class D

Other Products from FRISCH MEDICAL DEVICES PVT. LTD.

Products from the same license holder (10 products)

Brand: Steer-R

Class C

Introducer Sheath -Radial

Brand: Steer-R

Class C