SBO Bernafon Encanta ITE Hearing Aids - HSA Registration DE0510510

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.

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HSA Official Data

CLASS B

DE0510510

SBO Bernafon Encanta ITE Hearing Aids

HSA Registration Number: DE0510510

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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

DE0510510

Registration Date

March 26, 2025

Retention Due Date

March 25, 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)

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