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Singapore HSA registration DE0004243

Natus ALGO® 3i Newborn Hearing Screener

Singapore flagSingapore·CLASS B·Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)·Registered April 29, 2008
Device classification
Device Class
CLASS B
Medical Speciality Area
Neurology
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration information
Registration Number
DE0004243
Registration Date
April 29, 2008
Change Notification Approval Date
December 15, 2021
Retention Due Date
December 31, 2025
Product description
It is a portable, noninvasive device for screening the hearing of infants between the ages of 34 weeks corrected gestational age and 6 months. The screener uses AABR (Automated Auditory Brainstem Response) technology. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.
Product Owner
Name
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
Short Name
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
Address
2568 Bristol Circle, Oakville, Ontario, L6H 5S1, CANADA
Registrant
Name
SOMNOTEC (S) PTE. LTD.
Address
37 UBI CRESCENT, SINGAPORE 408586
Importer
Name
SOMNOTEC (S) PTE. LTD.
Address
37 UBI CRESCENT, SINGAPORE 408586
Model information
Model Name(s)
ALGO® 3i Newborn Hearing Screener Roll-stand Adapter NATUS POWER SUPPLLY
Model Identifier(s)
040695 040710 900611
About this record

Access comprehensive regulatory information for Natus ALGO® 3i Newborn Hearing Screener in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0004243 and owned by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK). The device was registered on April 29, 2008.

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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