Singapore HSA registration DE0014578
Interacoustics PC based Audiometers
Singapore·CLASS B·Interacoustics A/S·Registered January 02, 2014Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
- HSA Product Code
- HSAMDB00111
- HS Code
- 90214000
Registration information
- Registration Number
- DE0014578
- Registration Date
- January 02, 2014
- Change Notification Approval Date
- December 21, 2015
- Retention Due Date
- January 01, 2026
Product description
For the PC based audiometers, it is the choice of software module that decides which test that is performed. The intended uses are therefore connected to the software modules. The REM440 system is intended to be used as a system to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. The AC440 system is intended to be used for the detection and diagnosis of suspected hearing loss. The HIT440 system is intended to be used as a means to get an objective indication of the characteristics of a hearing aid and as a help for making the adjustments of the hearing aid to the patient. It is used by manufacturers of hearing aids and in clinics for hearing aid fitting. The HIT440 system may also be used with other approved Hearing aid test chambers.
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)
- Affinity Callisto Equinox VRA201
- Model Identifier(s)
- Affinity Callisto Equinox VRA201
About this record
Access comprehensive regulatory information for Interacoustics PC based Audiometers in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014578 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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