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Geenius Reader - HSA Registration DE0509774

Access comprehensive regulatory information for Geenius Reader in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0509774 and owned by Bio-Rad. The device was registered on September 11, 2024.

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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CLASS D IVD
DE0509774
Geenius Reader
HSA Registration Number: DE0509774
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Product Description

The Geeniusโ„ข Reader is intended for the reading of cassettes included in Bio-Rad test kits. Reactive bands on a cassette are detected by the onboard camera. The associated Geeniusโ„ข Software then performs the detection data analysis and the result evaluation according to predefined rules.

Device Classification
Device Class
CLASS D IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0509774
Registration Date
September 11, 2024
Retention Due Date
September 10, 2025
Product Owner
Short Name
Bio-Rad
Address
3, boulevard Raymond Poincare, 92430 Marnes-la-Coquette, FRANCE
Registrant
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model Information
Model Name(s)
Geenius Software Geenius Reader
Model Identifier(s)
92461 92465