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Singapore HSA registration DE0506245

Natus AURICAL FreeFit

Singapore flagSingapore·CLASS B·Natus Medical Denmark ApS·Registered October 01, 2021
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0506245
Registration Date
October 01, 2021
Change Notification Approval Date
April 03, 2025
Retention Due Date
September 30, 2025
Product description
Intended for audiologists, hearing instrument dispensers, ENTs, speech therapists and other health care professionals to visualize the amplified signal recorded in the ear with reference information such as target curves to provide an objective basis for adjusting the hearing instrument settings.
Product Owner
Name
Natus Medical Denmark ApS
Short Name
Natus Medical Denmark ApS
Address
Hoerskaetten 9, 2630 Taastrup, DENMARK
Registrant
Name
ACCESS-2-HEALTHCARE
Address
42 KIM YAM ROAD, OLEANAS RESIDENCE, #19-02, SINGAPORE 239347
Importer
Name
SUNDER MEDICAL PTE. LTD. Surgipro Pte Ltd
Address
73 AYER RAJAH CRESCENT, #03-22, SINGAPORE 139952 23 WOODLANDS INDUSTRIAL PARK E1, ADMIRALTY INDUSTRIAL PARK, #03-05, SINGAPORE 757741
Model information
Model Name(s)
1053 FREEFIT Otosuite® PC Software 1053 FreeFit REM Tube Thin 1053 Charger 1053 FreeFit REM Tube 1053 FREEFIT 1053 FreeFit REM Tube with Ruler 1053 REM Probe 1053 RECD Probe 1053 RECD Probe 1053 RECD Probes Foam Eartip, 3A (Standard) Foam Eartip, 3B (Small) Foam Eartip, 3C (Jumbo)
Model Identifier(s)
8-04-11808 8-49-75800 8-62-35100 8-62-39303 8-62-39400 8-62-49100 8-62-61000 8-69-39203 8-69-39205 8-69-39207 8-69-39210 80A4820900 80A4821000 80A4821100
About this record

Access comprehensive regulatory information for Natus AURICAL FreeFit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506245 and owned by Natus Medical Denmark ApS. The device was registered on October 01, 2021.

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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