Singapore HSA registration DE0507649
Jiangsu Medomics SARS-CoV-2 Antigen Test Kit (LFIA)
Singapore·CLASS D IVD·Jiangsu Medomics Medical Technology Co., Ltd.·Registered January 03, 2023Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0507649
- Registration Date
- January 03, 2023
- Change Notification Approval Date
- October 31, 2024
- Retention Due Date
- January 02, 2026
Product description
SARS-CoV-2 Antigen Test Kit (LFIA) is a colloidal gold immunochromatography for the rapid qualitative detection of SARS-CoV-2 nucleocapsid antigens present in human anterior nasal samples in vitro. The test kit is designed for use as self-testing. This test kit is intended for individuals by 18 or older with clinical symptoms of SARS-CoV-2 infection or who are suspected of COVID-19. If the suspected individual exhibits respiratory symptoms or suspected to be infected, it is recommended to combine PCR test, clinical symptoms, prevalence and further clinical data to confirm the diagnosis.
Product Owner
- Short Name
- Jiangsu Medomics Medical Technology Co., Ltd.
- Address
- F3, Building C, No.3-1 Xinjinhu Road, Jiangbei New Area, Nanjing, Jiangsu 210030, CHINA
Registrant
- Address
- 400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Importer
- Address
- 400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model information
- Model Name(s)
- SARS-CoV-2 Antigen Test Kit (LFIA) SARS-CoV-2 Antigen Test Kit (LFIA) SARS-CoV-2 Antigen Test Kit (LFIA) SARS-CoV-2 Antigen Test Kit (LFIA)
- Model Identifier(s)
- 1031-14-01 1031-24-01 1031-34-01 1031-54-01
About this record
Access comprehensive regulatory information for Jiangsu Medomics SARS-CoV-2 Antigen Test Kit (LFIA) 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 DE0507649 and owned by Jiangsu Medomics Medical Technology Co., Ltd.. The device was registered on January 03, 2023.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D IVD