Natus ALGO® 3i Newborn Hearing Screener - HSA Registration DE0004243
Access comprehensive regulatory information for Natus ALGO® 3i Newborn Hearing Screener in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0004243 and owned by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK). The device was registered on April 29, 2008.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
It is a portable, noninvasive device for screening the hearing of infants between the ages of 34 weeks corrected gestational age and 6 months. The screener uses AABR (Automated Auditory Brainstem Response) technology. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.