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Roffe International BUZUD Hearing Aids - HSA Registration DE0510263

Access comprehensive regulatory information for Roffe International BUZUD 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 DE0510263 and owned by Roffe International Holdings Pte Ltd. The device was registered on January 18, 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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CLASS B
DE0510263
Roffe International BUZUD Hearing Aids
HSA Registration Number: DE0510263
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Product Description

The hearing aids are used for hearing compensation of patients with mild to moderate air conduction hearing loss.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510263
Registration Date
January 18, 2025
Retention Due Date
January 17, 2026
Product Owner
Short Name
Roffe International Holdings Pte Ltd
Address
585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Registrant
Address
585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Importer
Address
585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Model Information
Model Name(s)
BUZUD Hearing Aids BUZUD Hearing Aids BUZUD Hearing Aids
Model Identifier(s)
121 A51 W6