MADSEN® Alpha OAE Screener
- UID
- IMP/MD/2023/000393_0369b9c38b1a88adee0955344ecf737e_76388178abef07bde9ad7d9850ba6f56
- Device class
- Class B
- Brand name
- Aurical® Freefit
- License holder
- Genworks Health Private Limited
- Approving authority
- CDSCO
- Product information
- The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (Aurical® Freefit) necessary for the diagnosis of auditory and hearing-related disorders
MADSEN® Alpha OAE Screener is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000393_0369b9c38b1a88adee0955344ecf737e_76388178abef07bde9ad7d9850ba6f56. 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.
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