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SBO OTICON INTENT HEARING AIDS (BTE) - HSA Registration DE0509035

Access comprehensive regulatory information for SBO OTICON INTENT HEARING AIDS (BTE) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509035 and owned by SBO Hearing A/S. The device was registered on March 07, 2024.

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.

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CLASS B
DE0509035
SBO OTICON INTENT HEARING AIDS (BTE)
HSA Registration Number: DE0509035
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Product Description

The hearing aid is intended to amplify and transmit sound to the ear. Indicated for bilateral or unilateral impaired hearing of sensorineural, conductive or mixed type ranging from a slight (16 dB HL*) to profound (95 dB HL*) degree of hearing loss, with an individual frequency configuration. Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief for patients suffering from tinnitus as part of a tinnitus management program. It is a feature built into the hearing aid.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0509035
Registration Date
March 07, 2024
Retention Due Date
March 06, 2026
Product Owner
Short Name
SBO Hearing A/S
Address
Kongebakken 9, 2765 Smørum, DENMARK
Registrant
Address
80 BENDEMEER ROAD, #06-01A, SINGAPORE 339949
Importer
Address
80 BENDEMEER ROAD, #06-01A, SINGAPORE 339949
Model Information
Model Name(s)
OTICON CHARGER MINIRITE OTICON SMARTCHARGER MINIRITE SALES PACK, DVD OTICON GENIE 2 2024.1 VAR SALES PACK, USB OTICON GENIE 2 2024.1 VAR OTICON INTENT 1 MINIRITE C090 OTICON INTENT 1 MINIRITE C092 OTICON INTENT 1 MINIRITE C091 OTICON INTENT 1 MINIRITE C093 OTICON INTENT 1 MINIRITE C044 OTICON INTENT 1 MINIRITE C094 OTICON INTENT 1 MINIRITE C063 OTICON INTENT 1 MINIRITE C115 OTICON INTENT 1 MINIRITE C116 OTICON INTENT 1 MINIRITE C090 DEMO OTICON INTENT 1 MINIRITE C093 DEMO OTICON INTENT 1 MINIRITE C063 DEMO OTICON INTENT 2 MINIRITE C090 OTICON INTENT 2 MINIRITE C092 OTICON INTENT 2 MINIRITE C091 OTICON INTENT 2 MINIRITE C093 OTICON INTENT 2 MINIRITE C044 OTICON INTENT 2 MINIRITE C094 OTICON INTENT 2 MINIRITE C063 OTICON INTENT 2 MINIRITE C115 OTICON INTENT 2 MINIRITE C116 OTICON INTENT 3 MINIRITE C090 OTICON INTENT 3 MINIRITE C092 OTICON INTENT 3 MINIRITE C091 OTICON INTENT 3 MINIRITE C093 OTICON INTENT 3 MINIRITE C044 OTICON INTENT 3 MINIRITE C094 OTICON INTENT 3 MINIRITE C063 OTICON INTENT 3 MINIRITE C115 OTICON INTENT 3 MINIRITE C116 OTICON INTENT 3 MINIRITE C090 DEMO OTICON INTENT 3 MINIRITE C093 DEMO OTICON INTENT 3 MINIRITE C063 DEMO OTICON INTENT 4 MINIRITE C090 OTICON INTENT 4 MINIRITE C092 OTICON INTENT 4 MINIRITE C091 OTICON INTENT 4 MINIRITE C093 OTICON INTENT 4 MINIRITE C044 OTICON INTENT 4 MINIRITE C094 OTICON INTENT 4 MINIRITE C063 OTICON INTENT 4 MINIRITE C115 OTICON INTENT 4 MINIRITE C116 OTICON COMPANION 1.3.0. Android OTICON COMPANION 1.3.0. iOS
Model Identifier(s)
265974 265986 268355 268377 269568 269576 269578 269579 269581 269582 269583 269584 269585 269589 269590 269591 269592 269593 269594 269595 269596 269597 269598 269599 269600 269601 269602 269603 269604 269605 269606 269607 269608 269609 269610 269611 269612 269613 269614 269615 269616 269617 269618 269619 269620 269621 OTICON COMPANION 1.3.0. Android OTICON COMPANION 1.3.0. iOS