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Natus Medical MADSEN A450 - HSA Registration DE0506248

Access comprehensive regulatory information for Natus Medical MADSEN A450 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506248 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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CLASS B
DE0506248
Natus Medical MADSEN A450
HSA Registration Number: DE0506248
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Product Description

MADSEN A450 is intended for audiologists, ENTs, hearing instrument dispensers and other health care professionals in testing the hearing of their patients for diagnostic and clinical audiometric testing.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0506248
Registration Date
October 01, 2021
Change Notification Approval Date
November 15, 2024
Retention Due Date
September 30, 2025
Product Owner
Short Name
Natus Medical Denmark ApS
Address
Hoerskaetten 9, 2630 Taastrup, DENMARK
Registrant
Address
42 KIM YAM ROAD, OLEANAS RESIDENCE, #19-02, SINGAPORE 239347
Importer
Address
73 AYER RAJAH CRESCENT, #03-22, SINGAPORE 139952
Model Information
Model Name(s)
BC-2 Bone Conductor with Headband BC-2 Receiver 1081 Madsen A450 1081 Madsen A450 1081 Madsen A450 1081 Madsen A450 Patient Responder (Black) Audiometer Otosuite๏ฟฝ PC Software Headset, HB-7, 8kHz matched TDH39 phones, jack Headset, HB-8, 8kHz matched TDH39 phones, jack Headset, ME70, w. 8 kHz Insert Earphone 10 Ohm, Stereo, Jack Foam Eartip, 3A (Standard) Foam Eartip, 3B (Small) Foam Eartip, 3C (Jumbo)
Model Identifier(s)
41545 41546 8-04-14567 8-04-14568 8-04-14667 8-04-14668 8-31-200 8-49-75800 8-75-430 8-75-435 8-75-770 8-75-81200 80A4820900 80A4821000 80A4821100