Software - India CDSCO Medical Device Registration

Software is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000054_719d067b229178f03bcfa1da4ac4dede_b15c9f25319078ca2c2ca0324382b789. This device is marketed under the brand name OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class B. 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.

Free Database

CDSCO Registered

Class Class B

Software

UID: IMP/MD/2019/000054_719d067b229178f03bcfa1da4ac4dede_b15c9f25319078ca2c2ca0324382b789

Brand Name

OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The AptiVue™ E series software is intended to be used only with compatible OPTIS™ imaging systems. The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is indicated for: • For qualitative and quantitative evaluation of vascular morphology in the coronary arteries. As an adjunct to conventional angiographic procedure to provide an image of vessel lumen and wall structures. • For imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedure. The system further computes and displays various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices

Class B

Software

Brand: TactiCath Ablation Catheter Sensor enabled Catheter Catalog Installation

M/s St. Jude Medical India Pvt. Ltd

Class B

Other Products from M/s St. Jude Medical India Pvt. Ltd

Products from the same license holder (10 products)

Brand: Merlin PCS 3650 Software

Class D

Cautery Unit

Brand: Disposable Sterile Electrocautery

Class C