Respiratory Humidifier - India CDSCO Medical Device Registration

Respiratory Humidifier is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000573_c14b8d431bb7f32a7b18cd69545781c2_7d20be917e24c0ffeb4e8b8add992fb2. This device is marketed under the brand name FL-9000. The license holder is FLEXICARE MEDICAL (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

Respiratory Humidifier

UID: IMP/MD/2022/000573_c14b8d431bb7f32a7b18cd69545781c2_7d20be917e24c0ffeb4e8b8add992fb2

Brand Name

FL-9000

License Holder

FLEXICARE MEDICAL (INDIA) PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

A mains electricity (FL-9000) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (FL-9000). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (FL-9000). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Respiratory Humidifier

Brand: MBS DIOFLEXI

Medibank Systems

Class B

Respiratory Humidifier

Brand: HekaFlo

Heka Medicals India Pvt Ltd

Class B

Brand: ProVu

Class A