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Singapore HSA registration DE0510511

SBO Bernafon Entra B ITE Hearing Aids

Singapore flagSingapore·CLASS B·SBO Hearing A/S·Registered March 26, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0510511
Registration Date
March 26, 2025
Retention Due Date
March 25, 2026
Product description
The hearing aid is intended to amplify and transmit sound to the ear. Refer to IFU for more information.
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)
Bernafon App Android Bernafon App iOS ENTRA B 20 KIT 312 NFM L BE ENTRA B 20 KIT 312 NFM R BE ENTRA B 20 KIT 312 2.4G NFM L BE ENTRA B 20 KIT 312 2.4G NFM R BE ENTRA B 10 KIT 312 NFM L BE ENTRA B 10 KIT 312 NFM R BE ENTRA B 10 KIT 312 2.4G NFM L BE ENTRA B 10 KIT 312 2.4G NFM R BE BERNAFON ENTRA B 20 IIC BERNAFON ENTRA B 20 CIC BERNAFON ENTRA B 20 ITC BERNAFON ENTRA B 20 ITE HS BERNAFON ENTRA B 20 ITE FS BERNAFON ENTRA B 10 IIC BERNAFON ENTRA B 10 CIC BERNAFON ENTRA B 10 ITC BERNAFON ENTRA B 10 ITE HS BERNAFON ENTRA B 10 ITE FS SALES PACK, USB BERNAFON OASISNXT ENTRA B 20 KIT 10 75 BE ENTRA B 20 KIT IIC 10 75 BL ENTRA B 20 KIT 10 90 BE ENTRA B 20 KIT IIC 10 90 BL ENTRA B 20 KIT 10 NFM 75 BE ENTRA B 20 KIT 10 NFM 90 BE ENTRA B 10 KIT 10 75 BE ENTRA B 10 KIT IIC 10 75 BL ENTRA B 10 KIT 10 90 BE ENTRA B 10 KIT IIC 10 90 BL ENTRA B 10 KIT 10 NFM 75 BE ENTRA B 10 KIT 10 NFM 90 BE
Model Identifier(s)
274910 274911 276802 276804 276810 276812 276822 276824 276830 276832 276892 276893 276894 276895 276896 276897 276898 276899 276900 276901 277275 280332 280333 280334 280335 280336 280337 280338 280339 280340 280341 280342 280343
About this record

Access comprehensive regulatory information for SBO Bernafon Entra B 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 DE0510511 and owned by SBO Hearing A/S. The device was registered on March 26, 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