HSA · registration DE0510263

Roffe International BUZUD Hearing Aids

Name: Roffe International BUZUD Hearing Aids — HSA DE0510263
Creator: Roffe International Holdings Pte Ltd
Keywords: Roffe International BUZUD Hearing Aids, Roffe International BUZUD Hearing Aids, DE0510263, General Hospital, HSA

SingaporeGeneral HospitalClass BRoffe International Holdings Pte Ltd

Verified

Official record identity

Registration number: DE0510263
Model name: BUZUD Hearing Aids; BUZUD Hearing Aids; BUZUD Hearing Aids
Model identifier: 121; A51; W6
Registration date: January 18, 2025

Classification

Risk class: Class B
Published category: General Hospital

Published parties

Product owner: Roffe International Holdings Pte Ltd
Registrant / registration holder: ROFFE INTERNATIONAL HOLDINGS PTE. LTD.

Official description

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

Additional source fields

Product owner address: 585 NORTH BRIDGE ROAD, #01-02, RAFFLES HOSPITAL, Singapore 188770
Registrant address: 585 NORTH BRIDGE ROAD, #01-02, RAFFLES HOSPITAL, Singapore 188770

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.