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Coronary Dilatation Catheter - India CDSCO Medical Device Registration

Coronary Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000050_fd4b8ea69c6295bd33f104c4d506ff3d_c23b6c5f69fc4c8cfeaa883855f0e6ab. This device is marketed under the brand name Sapphire 3. The license holder is Innvolution Healthcare Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.

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.

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CDSCO Registered
Class Class D
Coronary Dilatation Catheter
UID: IMP/MD/2020/000050_fd4b8ea69c6295bd33f104c4d506ff3d_c23b6c5f69fc4c8cfeaa883855f0e6ab

Brand Name

Sapphire 3

Device Class

Class D

Approving Authority

CDSCO

Product Information

For balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. โ€ข Post-stenting dilation to achieve stent optimization โ€ข Dilation of mildly to moderately calcified lesions

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