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Singapore HSA registration DE0016373

Interacoustics Hand Held Impedance Tympanometer MT10

Singapore flagSingapore·CLASS B·Interacoustics A/S·Registered October 03, 2014
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
HSA Product Code
HSAMDB00111
HS Code
90214000
Registration information
Registration Number
DE0016373
Registration Date
October 03, 2014
Change Notification Approval Date
December 21, 2015
Retention Due Date
October 02, 2025
Product description
The MT10 is a handheld screening tympanometer offering Tympanometry and optional Ipsi reflex testing. The MT10 allows storing of data by printing (optional printer) or by transferring data to a computer (optional software module). The MT10 tympanometer is intended to be used by an audiologist, hearing healthcare professional, or trained technician in a quiet environment (tymp and reflexes).
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)
Additional probe tip BET55 Diagnostic Suite software, version 2.0 MT10 MT10 MT10 MT10 MT10 MT10 MT10 MT10 MT10 MT10 MT10 MT10
Model Identifier(s)
8002592 8012892 8013046 8100118 8100126 8100131 8100135 8100387 8100395 8100396 8100398 8101354 8101355 8101852 8103108
About this record

Access comprehensive regulatory information for Interacoustics Hand Held Impedance Tympanometer MT10 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016373 and owned by Interacoustics A/S. The device was registered on October 03, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B