Singapore HSA registration DE0014582
Interacoustics Clinical Audiometer
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
- HSA Product Code
- HSAMDB00111
- HS Code
- 90214000
Registration information
- Registration Number
- DE0014582
- Registration Date
- January 02, 2014
- Change Notification Approval Date
- December 21, 2015
- Retention Due Date
- January 01, 2026
Product description
The clinical audiometer is designed to be a device for diagnosing hearing loss. The audiometer is intended to be used by an audiologist, hearing healthcare professional, or trained technician in an extremely quiet environment. It is recommended that the instrument be operated within an ambient temperature range of 15-35 degree Celsius (59-95 degrees Fahrenheit).
Product Owner
- Short Name
- Interacoustics A/S
- Address
- Audiometer Allé 1, 5500 Middelfart, DENMARK
Registrant
- Address
- 80 BENDEMEER ROAD, #06-01A, SINGAPORE 339949
Importer
- Address
- 80 BENDEMEER ROAD, #06-01A, SINGAPORE 339949
Model information
- Model Name(s)
- AC40 VRA201
- Model Identifier(s)
- AC40 VRA201
About this record
Access comprehensive regulatory information for Interacoustics Clinical 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 DE0014582 and owned by Interacoustics A/S. The device was registered on January 02, 2014.
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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