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Singapore HSA registration DE0502360

Interacoustics Sera

Singapore flagSingapore·CLASS B·Interacoustics A/S·Registered November 20, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0502360
Registration Date
November 20, 2018
Retention Due Date
November 19, 2025
Product description
The SeraTM with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for SeraTM with DPOAE includes all ages. The SeraTM with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for SeraTM with TEOAE includes all ages. The SeraTM with ABRIS is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for SeraTM with ABRIS is newborns
Product Owner
Name
Interacoustics A/S
Short Name
Interacoustics A/S
Address
Audiometer Allé 1, 5500 Middelfart, DENMARK
Registrant
Name
DEMANT SINGAPORE PTE LTD
Address
80 BENDEMEER ROAD, #06-01A, SINGAPORE 339949
Importer
Name
DEMANT SINGAPORE PTE LTD
Address
80 BENDEMEER ROAD, #06-01A, SINGAPORE 339949
Model information
Model Name(s)
ABRIS Pass Checker Cavity 0.2/0.5 cc HearSIM IP30 Insert earphones Infant EarCup with snap electrodes OWA probe Black Pinch clip cables for snap electrodes Preamplifier Pregel foam snap elec (PEG15) Sanibel tab electrodes Sera Sera Cradle
Model Identifier(s)
ABRIS Pass Checker Cavity 0.2/0.5 cc HearSIM IP30 Insert earphones Infant EarCup with snap electrodes OWA probe Black Pinch clip cables for snap electrodes Preamplifier Pregel foam snap elec (PEG15) Sanibel tab electrodes Sera Sera Cradle
About this record

Access comprehensive regulatory information for Interacoustics Sera in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502360 and owned by Interacoustics A/S. The device was registered on November 20, 2018.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B