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Singapore HSA registration DE0510425

SBO Oticon Jet PX 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
DE0510425
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)
OTICON COMPANION ANDROID OTICON COMPANION IOS JET PX 1 KIT 312 NFM L C001 JET PX 1 KIT 312 NFM R C001 JET PX 1 KIT 312 NFM 90 R C001 JET PX 1 KIT 312 NFM 90 L C001 JET PX 1 KIT 312 2.4G NFM L C001 JET PX 1 KIT 312 2.4G NFM R C001 JET PX 1 KIT 312 2.4G NFM 90 R C001 JET PX 1 KIT 312 2.4G NFM 90 L C001 JET PX 1 KIT 312 2.4G NFM L C005 JET PX 1 KIT 312 2.4G NFM R C005 JET PX 1 KIT 312 NFM L C005 JET PX 1 KIT 312 NFM R C005 JET PX 2 KIT 312 NFM L C001 JET PX 2 KIT 312 NFM R C001 JET PX 2 KIT 312 NFM 90 R C001 JET PX 2 KIT 312 NFM 90 L C001 JET PX 2 KIT 312 2.4G NFM L C001 JET PX 2 KIT 312 2.4G NFM R C001 JET PX 2 KIT 312 2.4G NFM 90 R C001 JET PX 2 KIT 312 2.4G NFM 90 L C001 JET PX 2 KIT 312 2.4G NFM L C005 JET PX 2 KIT 312 2.4G NFM R C005 JET PX 2 KIT 312 NFM L C005 JET PX 2 KIT 312 NFM R C005 OTICON JET PX 1 IIC OTICON JET PX 1 CIC OTICON JET PX 1 ITC OTICON JET PX 1 ITE HS OTICON JET PX 1 ITE FS OTICON JET PX 2 IIC OTICON JET PX 2 CIC OTICON JET PX 2 ITC OTICON JET PX 2 ITE HS OTICON JET PX 2 ITE FS SALES PACK, DVD OTICON GENIE 2 SALES PACK, USB OTICON GENIE 2 JET PX 1 KIT 10 75 C001 JET PX 1 KIT IIC 10 75 C005 JET PX 1 KIT 10 90 C001 JET PX 1 KIT IIC 10 90 C005 JET PX 1 KIT 10 NFM 75 C001 JET PX 1 KIT 10 NFM 90 C001 JET PX 2 KIT 10 75 C001 JET PX 2 KIT IIC 10 75 C005 JET PX 2 KIT 10 90 C001 JET PX 2 KIT IIC 10 90 C005 JET PX 2 KIT 10 NFM 75 C001 JET PX 2 KIT 10 NFM 90 C001
Model Identifier(s)
274918 274919 276762 276764 276766 276768 276770 276772 276774 276776 276778 276779 276780 276781 276782 276784 276786 276788 276790 276792 276794 276796 276798 276799 276800 276801 276882 276883 276884 276885 276886 276887 276888 276889 276890 276891 277161 277188 280344 280345 280346 280347 280348 280349 280350 280351 280352 280353 280354 280355
About this record

Access comprehensive regulatory information for SBO Oticon Jet PX 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 DE0510425 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