Singapore HSA registration DE0506932
Natus Madsen AccuScreen
Singapore·CLASS B·Natus Medical Denmark ApS·Registered June 03, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0506932
- Registration Date
- June 03, 2022
- Retention Due Date
- June 02, 2026
Product description
Madsen AccuScreen is indicated for use in the recording and automated analysis of human physiological data (screening auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders.
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
- 16 SHAW ROAD, KIN BUILDING, #01-04, SINGAPORE 367954 23 WOODLANDS INDUSTRIAL PARK E1, ADMIRALTY INDUSTRIAL PARK, #03-05, SINGAPORE 757741
Model information
- Model Name(s)
- Madsen AccuScreen AccuLink Software AccuScreen ABR/TE, Type 1077 AccuScreen TE, Type 1077 AccuScreen ABR/TE, Type 1077 AccuScreen ABR, Type 1077 AccuScreen DP, Type 1077 Accuscreen TE/DP, Type 1077 AccuScreen ABR, Type 1077 AccuScreen ABR/DP, Type 1077 AccuScreen ABR/TE/DP, Type 1077 AccuScreen TE, Type 1077 AccuScreen DP, Type 1077 1077 AccuScreen ABR/TE AccuScreen ABR/TE, Type 1077 AccuScreen ABR/TE/DP, Type 1077 1077 AccuScreen TE 1077 AccuScreen ABR/TE 1077 AccuScreen ABR/TE/DP 1077 AccuScreen ABR 1077 AccuScreen DP 1077 AccuScreen TE/DP 1077 AccuScreen ABR/DP 1077 AccuScreen ABR/TE/DP
- Model Identifier(s)
- 8-49-88800 8-04-13922 8-04-13923 8-04-13924 8-04-13925 8-04-13938 8-04-13939 8-04-13942 8-04-13943 8-04-13944 8-04-13970 8-04-13971 8-04-13974 8-04-13975 8-04-13976 8-04-13979 8-04-13980 8-04-13981 8-04-13982 8-04-13983 8-04-13984 8-04-13985 8-04-13986
About this record
Access comprehensive regulatory information for Natus Madsen AccuScreen in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506932 and owned by Natus Medical Denmark ApS. The device was registered on June 03, 2022.
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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