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Bio-Rad OptiMAL-IT - HSA Registration DE0012636

Access comprehensive regulatory information for Bio-Rad OptiMAL-IT in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0012636 and owned by Bio-Rad. The device was registered on March 25, 2013.

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 C IVD
DE0012636
Bio-Rad OptiMAL-IT
HSA Registration Number: DE0012636
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Product Description

OptiMAL-IT is a rapid malaria test, is intended for diagnosis and therapy control of an infection by Plasmodium species (Malaria).

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration Information
Registration Number
DE0012636
Registration Date
March 25, 2013
Change Notification Approval Date
October 18, 2018
Retention Due Date
March 24, 2026
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)
OptiMal Positive Control OptiMal-IT
Model Identifier(s)
710011 710024