Singapore HSA registration DE0510614
Genea Biomedx GERI/GERI+ Incubator System
Singapore·CLASS B·Genea Biomedx Pty Ltd·Registered April 22, 2025Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Obstetrics & Gynaecology
Registration information
- Registration Number
- DE0510614
- Registration Date
- April 22, 2025
- Retention Due Date
- April 21, 2026
Product description
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.
Product Owner
- Short Name
- Genea Biomedx Pty Ltd
- Address
- Level 2, 321 Kent Street, Sydney, New South Wales, 2000, AUSTRALIA
Registrant
- Address
- HONGKONG STREET, HOLY BUILDING, #03-01, SINGAPORE 059675
Importer
- Address
- 1 BUKIT BATOK CRESCENT, WCEGA PLAZA, #03-13/14, SINGAPORE 658064
Model information
- Model Name(s)
- Geri Dish Geri Connect Server Geri Incubator Geri+ Incubator GERI SOFTWARE CONNECT AND ASSESS 2.0 Geri Water Bottle
- Model Identifier(s)
- GERI-DSH-20 GERI-GCS-02 GERI-INS-01 GERI-INS-02 GERI-SCA-05 GERI-WAT-12
About this record
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.
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