Genea Biomedx GERI/GERI+ Incubator System - HSA Registration DE0510614
Access comprehensive regulatory information for Genea Biomedx GERI/GERI+ Incubator System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510614 and owned by Genea Biomedx Pty Ltd. The device was registered on April 22, 2025.
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.
The intended use of the incubator shall be to store and preserve embryos at or near body temperature. Geri is designed to accurately maintain: a user-specified temperature within the range of +35°C to +40°C for each of the instrument’s chambers. Geri incubator (GERI-INS-01) incubator is fitted with time-lapse imaging system using only bright-field optics. Geri+ incubator (GERI-INS-02) incubator is fitted with time-lapse imaging system using both bright-field and dark-field optics.