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Singapore HSA registration DE0503821

Interacoustics AD528

Singapore flagSingapore·CLASS B·Interacoustics A/S·Registered November 18, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0503821
Registration Date
November 18, 2019
Retention Due Date
November 17, 2025
Product description
AD528 is an audiometer offering air, bone, speech, and free field line output. It offers a wide range of clinical test features such as SISI, ABLB, Stenger and Bekesy. AD528 is intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders.
Product Owner
Name
Interacoustics A/S
Short Name
Interacoustics A/S
Address
Audiometer Allé 1, 5500 Middelfart, 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)
AD528 APS3 B71 DD45 HBA DD45 P3045 DD45 P3100 DD450 Diagnostic Suite EM400 EMS400 IP30 10 Ohm MTH400m Mic speech Sound Kit
Model Identifier(s)
AD528 APS3 B71 DD45 HBA DD45 P3045 DD45 P3100 DD450 Diagnostic Suite EM400 EMS400 IP30 10 Ohm MTH400m Mic speech Sound Kit
About this record

Access comprehensive regulatory information for Interacoustics AD528 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503821 and owned by Interacoustics A/S. The device was registered on November 18, 2019.

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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