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Amplivox modelONE Screening Audiometer - HSA Registration DE0508402

Access comprehensive regulatory information for Amplivox modelONE Screening Audiometer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508402 and owned by Amplivox Limited. The device was registered on August 17, 2023.

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
DE0508402
Amplivox modelONE Screening Audiometer
HSA Registration Number: DE0508402
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Product Description

The Amplivox modelONE audiometer is intended to perform automated audiometry using the ampliSuite BEEP application. This includes presenting a test tone, defining test level and frequency, recording patient responses and using a built-in microphone to monitor environmental noise levels so as to perform a test.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0508402
Registration Date
August 17, 2023
Retention Due Date
August 16, 2025
Product Owner
Short Name
Amplivox Limited
Address
3800 Parkside, Solihull Parkway, Birmingham Business Park, West Midlands B37 7YG, Birmingham, UNITED KINGDOM
Registrant
Address
80 BENDEMEER ROAD, #06-01A, SINGAPORE 339949
Importer
Address
80 BENDEMEER ROAD, #06-01A, SINGAPORE 339949
Model Information
Model Name(s)
Cable USB Type C to mini 4P Amplisuite BEEP Bundle USB-C to USB-A Adapter Patient response switch Shoulder bag 245x225x145mm-Amplivox logo modelONE Screening Audiometer
Model Identifier(s)
8518615 8524375 8526453 8528431 8531412 8531884