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INTERACOUSTICS EQUINOX EVO - HSA Registration DE0510682

Access comprehensive regulatory information for INTERACOUSTICS EQUINOX EVO in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510682 and owned by Interacoustics A/S. The device was registered on May 06, 2025.

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
DE0510682
INTERACOUSTICS EQUINOX EVO
HSA Registration Number: DE0510682
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Product Description

The Equinox Evo with AC440 module is an audiometer that generates specific tonal, speech and noise stimuli for audiometric tests. The behavioural response of the subject can be recorded automatically or manually depending on the audiometric test.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0510682
Registration Date
May 06, 2025
Retention Due Date
May 05, 2026
Product Owner
Short Name
Interacoustics A/S
Address
Audiometer Allรฉ 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)
HBA Audiometric Headband IP30, 10 โ„ฆ Equinox Suite APS3 patient response switch DD45 audiometric headset DD45AA DD45 RE-7 DD45 audiometric headset P3045 DD45 audiometric headset P3100 B71 Bone conductor only B81 Bone conductor only Headband P3045 Adult Easy Adjust DD45 Headband P3100 Pediatric easy adjust DD45 P3333 headband, for B71 / B81 DD45 10 Ohm Earphone B71 bone conductor, complete, 30ยฐ plug B81 bone conductor, complete, 30ยฐ plug DD450 high frequency headset DD65v2 headset INTERACOUSTICS EQUINOX EVO
Model Identifier(s)
8010817 8101884 8102246 8103838 8106339 8106343 8106352 8503851 8503852 8506731 8506737 8507208 8507210 8507213 8507268 8510370 8510371 8520321 8520328 8533212