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PTCA Balloon Catheter - India CDSCO Medical Device Registration

PTCA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000053_35f2171fa613585bd5d0311eff170695_8aeb0e2c806c3a9431a326df51c865c3. This device is marketed under the brand name FlexiTrack SC, FlexiTrack NC. The license holder is Sahajanand Laser Technology Limited (SLTL), and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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
PTCA Balloon Catheter
UID: MFG/MD/2021/000053_35f2171fa613585bd5d0311eff170695_8aeb0e2c806c3a9431a326df51c865c3

Brand Name

FlexiTrack SC, FlexiTrack NC

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

PTCA Balloon Catheter is intended to be used for Percutaneous Transluminal Coronary Angioplasty (FlexiTrack SC, FlexiTrack NC) for the purpose of improving myocardial blood flow in the localized stenotic lesions of coronary arteries

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