Singapore HSA registration DE0506930
Natus 1079 ICS Aircal Air Caloric Irrigator
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
- DE0506930
- Registration Date
- June 03, 2022
- Retention Due Date
- June 02, 2026
Product description
An air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of airflow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produces involuntary eye movements that are measured and recorded by a nystagmograph.
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
- 160 ROBINSON ROAD, SINGAPORE BUSINESS FEDERATION CENTER, #14-04, SINGAPORE 068914
Model information
- Model Name(s)
- 1079 ICS Aircal 1079 ICS Aircal
- Model Identifier(s)
- 8-04-13321 8-04-13322
About this record
Access comprehensive regulatory information for Natus 1079 ICS Aircal Air Caloric Irrigator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506930 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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