Singapore HSA registration DE0504499
Interacoustics Affinity Compact
Singapore·CLASS B·Interacoustics A/S·Registered May 21, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0504499
- Registration Date
- May 21, 2020
- Retention Due Date
- May 20, 2025
Product description
The Affinity Compact with AC440 is intended to be used for the detection and diagnosis of suspected hearing loss. The Affinity Compact with HIT440 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 Affinity Compact with REM440 is intended to be used for Real-Ear Measurement that takes care of all clinical verification needs.
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)
- Ear Simulator DD45 Audiometric Headset DD65 Audiometric Headset SPL60 Transducer kit for RECD measurement including probes and eartips DD45 Audiometric Headset IP30 insert earphones B71 Bone Conductor APS3 Patient Response Switch HDA300 Audiometric Headset B81 Bone Conductor DD45 Audiometric Headset DD45 Audiometric Headset DD450 High Frequency Headset IP30 insert earphones Affinity Compact Version 1 Affinity Compact Version 2 Affinity Compact Version 3 Affinity Compact Version 4 Coupler kit - Affinity Compact IHM65 In-situ headset Power supply - UES65-240250SPA3
- Model Identifier(s)
- 8006505 8010879 8010902 8011379 8030458 8101884 8102514 8103838 8103867 8104119 8105268 8105270 8106236 8108559 8511426 8511427 8511428 8511429 8514594 8515010 8524210
About this record
Access comprehensive regulatory information for Interacoustics Affinity Compact in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504499 and owned by Interacoustics A/S. The device was registered on May 21, 2020.
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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