SBO Oticon Play PX miniBTE Hearing Aids - HSA Registration DE0510589

Access comprehensive regulatory information for SBO Oticon Play PX 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 DE0510589 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.

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HSA Official Data

CLASS B

DE0510589

SBO Oticon Play PX miniBTE Hearing Aids

HSA Registration Number: DE0510589

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Product Description

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. Meant for adults and children older than 36 months.

Device Classification

Device Class

CLASS B

Medical Speciality Area

Ear, Nose & Throat

Registration Information

Registration Number

DE0510589

Registration Date

April 11, 2025

Retention Due Date

April 10, 2026

Product Owner

Name

SBO Hearing A/S

Short Name

SBO Hearing A/S

Address

Kongebakken 9, 2765 Smørum, DENMARK

Registrant

Name

DEMANT SINGAPORE PTE LTD

Address

80 BENDEMEER ROAD, #06-01A, SINGAPORE 339949

Importer

Name

DEMANT SINGAPORE PTE LTD

Address

80 BENDEMEER ROAD, #06-01A, SINGAPORE 339949

Model Information

Model Name(s)

OTICON, CHARGER 1.0 MINIBTE R OTICON PLAY PX 1, MINIBTE T C090 OTICON PLAY PX 1, MINIBTE T C093 OTICON PLAY PX 1, MINIBTE T C044 OTICON PLAY PX 1, MINIBTE T C094 OTICON PLAY PX 1, MINIBTE T C063 OTICON PLAY PX 1, MINIBTE T C079 OTICON PLAY PX 1, MINIBTE T C047 OTICON PLAY PX 1, MINIBTE T C046 OTICON PLAY PX 1, MINIBTE T C045 OTICON PLAY PX 1, MINIBTE T C048 OTICON PLAY PX 1, MINIBTE T C057 OTICON PLAY PX 1, MINIBTE T C058 OTICON PLAY PX 1, MINIBTE T C090 DEMO OTICON PLAY PX 2, MINIBTE T C090 OTICON PLAY PX 2, MINIBTE T C093 OTICON PLAY PX 2, MINIBTE T C044 OTICON PLAY PX 2, MINIBTE T C094 OTICON PLAY PX 2, MINIBTE T C063 OTICON PLAY PX 2, MINIBTE T C079 OTICON PLAY PX 2, MINIBTE T C047 OTICON PLAY PX 2, MINIBTE T C046 OTICON PLAY PX 2, MINIBTE T C045 OTICON PLAY PX 2, MINIBTE T C048 OTICON PLAY PX 2, MINIBTE T C057 OTICON PLAY PX 2, MINIBTE T C058 OTICON PLAY PX 1, MINIBTE R C090 OTICON PLAY PX 1, MINIBTE R C093 OTICON PLAY PX 1, MINIBTE R C044 OTICON PLAY PX 1, MINIBTE R C094 OTICON PLAY PX 1, MINIBTE R C063 OTICON PLAY PX 1, MINIBTE R C079 OTICON PLAY PX 1, MINIBTE R C047 OTICON PLAY PX 1, MINIBTE R C046 OTICON PLAY PX 1, MINIBTE R C045 OTICON PLAY PX 1, MINIBTE R C048 OTICON PLAY PX 1, MINIBTE R C057 OTICON PLAY PX 1, MINIBTE R C058 OTICON PLAY PX 1, MINIBTE R C090 DEMO OTICON PLAY PX 2, MINIBTE R C090 OTICON PLAY PX 2, MINIBTE R C093 OTICON PLAY PX 2, MINIBTE R C044 OTICON PLAY PX 2, MINIBTE R C094 OTICON PLAY PX 2, MINIBTE R C063 OTICON PLAY PX 2, MINIBTE R C079 OTICON PLAY PX 2, MINIBTE R C047 OTICON PLAY PX 2, MINIBTE R C046 OTICON PLAY PX 2, MINIBTE R C045 OTICON PLAY PX 2, MINIBTE R C048 OTICON PLAY PX 2, MINIBTE R C057 OTICON PLAY PX 2, MINIBTE R C058 SALES PACK, DVD OTICON GENIE 2 SALES PACK, USB OTICON GENIE 2

Model Identifier(s)

226352 234822 234823 234824 234825 234826 234827 234828 234829 234830 234831 234832 234833 234834 234840 234841 234842 234843 234844 234845 234846 234847 234848 234849 234850 234851 236366 236367 236368 236369 236370 236371 236372 236373 236374 236375 236376 236377 236378 236379 236380 236381 236382 236383 236384 236385 236386 236387 236388 236389 236390 237469 237493