Singapore HSA registration DE0506248
Natus Medical MADSEN A450
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 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.
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� 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B