Bubble CPAP Delivery System - India CDSCO Medical Device Registration

Bubble CPAP Delivery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000505_d6316b5368e04a72e99e8fd4c842ccb7_7abc296d8c7e9ff5d0148cc4f8c11b53. The license holder is Fisher & Paykel Healthcare India Pvt Ltd, and it is classified as Device Class Class C. 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 C

Bubble CPAP Delivery System

UID: IMP/MD/2021/000505_d6316b5368e04a72e99e8fd4c842ccb7_7abc296d8c7e9ff5d0148cc4f8c11b53

License Holder

Fisher & Paykel Healthcare India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Fisher & Paykel Healthcare Bubble CPAP System is intended to provide CPAP to spontaneously breathing neonates and infants who require breathing support due to conditions associated with prematurity ##PLACEHOLDER_0## or other conditions where CPAP is required or desired and is prescribed by a physician. The Bubble CPAP System is for use in the hospital clinical environment such as the NICU ##PLACEHOLDER_0## and PICU ##PLACEHOLDER_0##. The intended patient population is premature and full term neonates up to a weights of 10kg.