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Singapore HSA registration DE0510510

SBO Bernafon Encanta 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
DE0510510
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.
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)
ENCANTA 400 KIT 10 75 BE ENCANTA 400 KIT IIC 10 75 BL ENCANTA 400 KIT 10 90 BE ENCANTA 400 KIT IIC 10 90 BL ENCANTA 400 KIT 10 NFM 75 BE ENCANTA 400 KIT 10 NFM 90 BE ENCANTA 300 KIT 10 75 BE ENCANTA 300 KIT IIC 10 75 BL ENCANTA 300 KIT 10 90 BE ENCANTA 300 KIT IIC 10 90 BL ENCANTA 300 KIT 10 NFM 75 BE ENCANTA 300 KIT 10 NFM 90 BE ENCANTA 200 KIT 10 75 BE ENCANTA 200 KIT IIC 10 75 BL ENCANTA 200 KIT 10 90 BE ENCANTA 200 KIT IIC 10 90 BL ENCANTA 200 KIT 10 NFM 75 BE ENCANTA 200 KIT 10 NFM 90 BE ENCANTA 100 KIT 10 75 BE ENCANTA 100 KIT IIC 10 75 BL ENCANTA 100 KIT 10 90 BE ENCANTA 100 KIT IIC 10 90 BL ENCANTA 100 KIT 10 NFM 75 BE ENCANTA 100 KIT 10 NFM 90 BE BERNAFON ENCANTA 400 IIC BERNAFON ENCANTA 400 CIC BERNAFON ENCANTA 300 IIC BERNAFON ENCANTA 300 CIC BERNAFON ENCANTA 200 IIC BERNAFON ENCANTA 200 CIC BERNAFON ENCANTA 100 IIC BERNAFON ENCANTA 100 CIC Bernafon App Android Bernafon App iOS SALES PACK, USB BERNAFON OASISNXT
Model Identifier(s)
271102 271103 271104 271105 271106 271107 271108 271109 271110 271111 271112 271113 271114 271115 271116 271117 271118 271119 271120 271121 271122 271123 271124 271125 271199 271200 271201 271202 271203 271204 271205 271206 274910 274911 277275
About this record

Access comprehensive regulatory information for SBO Bernafon Encanta 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 DE0510510 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