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Singapore HSA registration DE0510426

SBO Oticon Own SI ITE Hearing Aids

Singapore flagSingapore·CLASS B·SBO Hearing A/S·Registered March 05, 2025
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 description
The hearing aid is intended to amplify and transmit sound to the ear.
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
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B