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Singapore HSA registration DE0508796

Jiangsu Medomics SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA)

Singapore flagSingapore·CLASS D IVD·Jiangsu Medomics Medical Technology Co., Ltd.·Registered December 28, 2023
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0508796
Registration Date
December 28, 2023
Retention Due Date
December 27, 2025
Product description
SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2, Influenza A and Influenza B virus antigen in swab samples from individuals suspected of COVID-19, Influenza A and Influenza B within the first seven days of symptom onset. SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) shall not be used as sole basis to diagnose or exclude SARS- CoV-2, Influenza A and Influenza B infection.
Product Owner
Name
Jiangsu Medomics Medical Technology Co., Ltd.
Short Name
Jiangsu Medomics Medical Technology Co., Ltd.
Address
F3, Building C & D, No. 3-1 Xinjinhu Road, Jiangbei New District, Nanjing, Jiangsu, China, CHINA
Registrant
Name
UNISON COLLABORATIVE PTE. LTD.
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Importer
Name
UNISON COLLABORATIVE PTE. LTD.
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model information
Model Name(s)
SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA)
Model Identifier(s)
1041-102-01 1041-122-01 1041-202-01 1041-222-01 1041-302-01 1041-322-01 1041-502-01 1041-522-01 1041-702-01 1041-722-01 1041-902-01 1041-922-01
About this record

Access comprehensive regulatory information for Jiangsu Medomics SARS-CoV-2 & Influenza A/B Antigen Combo Rapid 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 DE0508796 and owned by Jiangsu Medomics Medical Technology Co., Ltd.. The device was registered on December 28, 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