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HSA · registration DE0509774

Geenius Reader

SingaporeMicrobiologyClass DBio-Rad
Official record identity
Registration number
DE0509774
Model name
Geenius Software; Geenius Reader
Model identifier
92461; 92465
Registration date
September 11, 2024
Classification
Risk class
Class D
Official value: CLASS D
Published category
Microbiology
Published parties
Product owner
Bio-Rad
Registrant / registration holder
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Official description

The Geenius™ 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 Geenius™ Software then performs the detection data analysis and the result evaluation according to predefined rules.

Additional source fields
Product owner address
3, boulevard Raymond Poincare, 92430 Marnes-la-Coquette, France
Registrant address
3A INTERNATIONAL BUSINESS PARK, #11-10/16, ICON@IBP, Singapore 609935
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.