Singapore HSA registration DE0509579
Jiangsu Medomics KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA)
Singapore·CLASS C IVD·Jiangsu Medomics Medical Technology Co., Ltd.·Registered July 24, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0509579
- Registration Date
- July 24, 2024
- Retention Due Date
- July 23, 2025
Product description
KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) is a colloidal gold immunochromatography for the rapid qualitative detection of KPC, IMP, NDM, VIM and OXA-48 carbapenemases in bacterial samples obtained after culture.
Product Owner
- Short Name
- Jiangsu Medomics Medical Technology Co., Ltd.
- Address
- F3, Building C, No.3-1 Xinjinhu Road, Jiangbei New Area, Nanjing, 210030 Jiangsu, CHINA
Registrant
- Name
- ARQON PTE. LTD.
- Address
- 221 HENDERSON ROAD, HENDERSON BUILDING, #02-08, SINGAPORE 159557
Importer
- Address
- 400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model information
- Model Name(s)
- KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA)
- Model Identifier(s)
- 211045-01-01 211045-20-01
About this record
Access comprehensive regulatory information for Jiangsu Medomics KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) 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 DE0509579 and owned by Jiangsu Medomics Medical Technology Co., Ltd.. The device was registered on July 24, 2024.
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 C IVD