11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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Bladder Scanner (Models: M2, M2-W, M1, M1-W)
FDA 510(k)
FDA Class 2
·Radiology
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)
FDA Enforcement
Class II
·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026
FN-W(IN)-1,FN-W(IN)-2
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Jiaxing Funing Medical Instrument Co.,Ltd.·3 devices
Ebola Virus Real Time PCR Kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
Ebola Virus Real Time PCR Kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
Monkeypox Virus Detection Real Time PCR Kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
Monkeypox Virus Detection Real Time PCR Kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
Monkeypox Virus (MPXV) Fast Real Time PCR Kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
Monkeypox Virus (MPXV) Fast Real Time PCR Kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
COVID-19 Coronavirus Real Time PCR Kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
Cortisol(CLIA)、Cortisol Calibrators
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices