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Jiangsu Medomics KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) - HSA Registration DE0509579

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.

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CLASS C IVD
DE0509579
Jiangsu Medomics KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA)
HSA Registration Number: DE0509579
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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.

Device 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 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
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