Madsen® Astera 2 - India CDSCO Medical Device Registration

Madsen® Astera 2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000393_64a9dc06ca69b40a8fe105530bdf8c0a_61b7cea44ea691704d6caa38c5135b62. This device is marketed under the brand name Aurical® Freefit. The license holder is Genworks Health 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

Madsen® Astera 2

UID: IMP/MD/2023/000393_64a9dc06ca69b40a8fe105530bdf8c0a_61b7cea44ea691704d6caa38c5135b62

Brand Name

Aurical® Freefit

License Holder

Genworks Health Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Madsen® Astera² is used to conduct diagnostic and clinical audiometric testing, thereby providing a means to determine the presence, type and degree of hearing loss, assist in the diagnosis of otologic disorders, and provide input for hearing aid programming

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Aurical® Aud

Brand: Aurical® Freefit

Genworks Health Private Limited

Madsen® Astera 2 - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Aurical® Aud

ICS Impulse®

Aurical® Freefit

Madsen A450

Aurical HIT

Madsen Zodiac

ICS Aircal

MADSEN® Alpha OAE Screener

Vyntus® IOS

Vyntus® ONE

Vyntus® SPIRO

Vyntus® CPX

Vyntus® ECG

Vyntus™ WALK

Vyntus™ BODY

Vyntus® APS

Vyntus® PNEUMO

Thermocoagulator