SBO Oticon Zircon miniBTE Hearing Aids - HSA Registration DE0510588
Access comprehensive regulatory information for SBO Oticon Zircon miniBTE Hearing Aids in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510588 and owned by SBO Hearing A/S. The device was registered on April 11, 2025.
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 hearing aid is intended to amplify and transmit sound to the ear. Bilateral or unilateral impaired hearing of sensorineural, conductive or mixed type ranging from a slight (16 dB HL) to moderately severe (75 dB HL) degree of hearing loss, with an individual frequency configuration.