SBO Oticon Own SI ITE Hearing Aids - HSA Registration DE0510426

Access comprehensive regulatory information for SBO Oticon Own SI ITE 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 DE0510426 and owned by SBO Hearing A/S. The device was registered on March 05, 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

DE0510426

SBO Oticon Own SI ITE Hearing Aids

HSA Registration Number: DE0510426

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Product Description

The hearing aid is intended to amplify and transmit sound to the ear.

Device Classification

Device Class

CLASS B

Medical Speciality Area

Ear, Nose & Throat

Registration Information

Registration Number

DE0510426

Registration Date

March 05, 2025

Retention Due Date

March 04, 2026

Product Owner

Name

SBO Hearing A/S

Short Name

SBO Hearing A/S

Address

Kongebakken 9, DK-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)

OWN SI 1 KIT 10 75 C001 OWN SI 1 KIT IIC 10 75 C005 OWN SI 1 KIT 10 90 C001 OWN SI 1 KIT IIC 10 90 C005 OWN SI 1 KIT 10 NFM 75 C001 OWN SI 1 KIT 10 NFM 90 C001 OWN SI 2 KIT 10 75 C001 OWN SI 2 KIT IIC 10 75 C005 OWN SI 2 KIT 10 90 C001 OWN SI 2 KIT IIC 10 90 C005 OWN SI 2 KIT 10 NFM 75 C001 OWN SI 2 KIT 10 NFM 90 C001 OWN SI 3 KIT 10 75 C001 OWN SI 3 KIT IIC 10 75 C005 OWN SI 3 KIT 10 90 C001 OWN SI 3 KIT IIC 10 90 C005 OWN SI 3 KIT 10 NFM 75 C001 OWN SI 3 KIT 10 NFM 90 C001 OWN SI 4 KIT 10 75 C001 OWN SI 4 KIT IIC 10 75 C005 OWN SI 4 KIT 10 90 C001 OWN SI 4 KIT IIC 10 90 C005 OWN SI 4 KIT 10 NFM 75 C001 OWN SI 4 KIT 10 NFM 90 C001 OTICON OWN SI 1 IIC OTICON OWN SI 1 CIC OTICON OWN SI 2 IIC OTICON OWN SI 2 CIC OTICON OWN SI 3 IIC OTICON OWN SI 3 CIC OTICON OWN SI 4 IIC OTICON OWN SI 4 CIC OTICON COMPANION ANDROID OTICON COMPANION IOS SALES PACK, DVD OTICON GENIE 2 SALES PACK, USB OTICON GENIE 2

Model Identifier(s)

271126 271127 271128 271129 271130 271131 271132 271133 271134 271135 271136 271137 271138 271139 271140 271141 271142 271143 271144 271145 271146 271147 271148 271149 271191 271192 271193 271194 271195 271196 271197 271198 274918 274919 277161 277188