Insufflator System - India CDSCO Medical Device Registration

Insufflator System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000431_766f84e9bdae287490c2503c65849c36_ea04434d9b5d450713cd192762a0c2df. This device is marketed under the brand name AirSeal® iFS System. The license holder is M/s Linvatec India Private Limited, 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

Insufflator System

UID: IMP/MD/2019/000431_766f84e9bdae287490c2503c65849c36_ea04434d9b5d450713cd192762a0c2df

Brand Name

AirSeal® iFS System

License Holder

M/s Linvatec India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The SurgiQuestAirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument is used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Brand: 60-2450-230

Class C