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Amplivox Model 270+ - HSA Registration DE0509374

Access comprehensive regulatory information for Amplivox Model 270+ in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509374 and owned by Amplivox Limited. The device was registered on June 10, 2024.

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
DE0509374
Amplivox Model 270+
HSA Registration Number: DE0509374
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Product Description

The Amplivox Model 270+ audiometer is designed for use by trained personnel only, such as audiologists, ENT surgeons, doctors, general practitioners, hearing aid dispensers, child health professionals and hearing healthcare professionals with a similar level of education. It is not recommended to use the equipment without the necessary knowledge and training. The audiometer is capable of undertaking both air and bone conduction tests with or without masking and has many additional features such as the facility to support speech audiometry from live or recorded sources, the option to select free field equivalent output from the headphones in speech mode and a range of clinical audiometry tests.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0509374
Registration Date
June 10, 2024
Retention Due Date
June 09, 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)
Patient response switch MPT-II Printer Amplivox Model 270+ Audiometer Bone vibrator headset B71 Audiometric headset, Earphones DD45 Operating Manual & ampliSuite on USB stick
Model Identifier(s)
8011155 8503007 8514279 8517050 8517340 8517684