Singapore HSA registration DE0009534
Natus ALGO 5 Newborn Hearing Screener
Singapore·CLASS B·Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)·Registered August 17, 2012Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Neurology
- HSA Product Code
- HSAMDB00104
- HS Code
- 90191010
Registration information
- Registration Number
- DE0009534
- Registration Date
- August 17, 2012
- Change Notification Approval Date
- October 11, 2022
- Retention Due Date
- August 16, 2025
Product description
The ALGO 5 Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses AABR® (Automated Auditory Brainstem Response) technology. The ALGO 5 also includes Natus Medical’s audble® Data Management software pre-installed. The screener is intended for babies between the ages of 34 weeks (gestational age) and six months. 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
- Short Name
- Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
- Address
- 2568 Bristol Circle, Oakville, Ontario, L6H 5S1, CANADA
Registrant
- Address
- 37 UBI CRESCENT, SINGAPORE 408586
Importer
- Address
- 37 UBI CRESCENT, SINGAPORE 408586
Model information
- Model Name(s)
- PCA 5 Assembly ALGO 5 Jelly Tab Sensors Sample Pack ALGO Pak - 36 sets of supplies User Manual (CD), ALGO 5 230V EU ALGO 5 230V UK ALGO 5 NuPrep Gel Report Form Stickers Barcode Scanner ALGO Equipment Check Kit Valu-Pak - 300 sets of supplies LAN Isolator Laser Page Printer PreAmp 5 Cable ATA 5 Cable User Manual, ALGO 5 Printer Labels Label Printer
- Model Identifier(s)
- 000696 010130 040517 040532 040546 1004 10131 10134 102566N 40372 40497 40527 40670 40948 40951 698 699 737 900404 954
About this record
Access comprehensive regulatory information for Natus ALGO 5 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 DE0009534 and owned by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK). The device was registered on August 17, 2012.
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