Natus ALGO 5 Newborn Hearing Screener - HSA Registration DE0009534
Access comprehensive regulatory information for Natus ALGO 5 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 DE0009534 and owned by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK). The device was registered on August 17, 2012.
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.
The ALGO 5 Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses AABR® (Automated Auditory Brainstem Response) technology. The ALGO 5 also includes Natus Medical’s audble® Data Management software pre-installed. The screener is intended for babies between the ages of 34 weeks (gestational age) and six months. 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.