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EU IVDR Class B In Vitro Diagnostic Devices
View 3893 EU IVDR Class B In Vitro Diagnostic Devices on BEUDAMED, the Better Database on Medical Devices. EU IVDR Class B IVDs are moderate-risk diagnostic products that can include reagents, instruments, and standalone software with potential impacts on patient or public health. These devices generally require notified body involvement for conformity assessment and proportionate clinical and performance evidence.
Class B devices must meet IVDR requirements for technical documentation, analytical and clinical performance, and post-market surveillance. Manufacturers need risk management records, traceability, and vigilance processes to support market access and ongoing compliance with the regulation.
ACTIVE® IGFBP-3 IRMA
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·IMMUNOTECH s.r.o.·1 device
RIDASCREEN® Calprotectin
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·R-Biopharm AG·4 devices
ALKALINE PHOSPHATASE (ALP)
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Medicon Hellas SA·5 devices
MR Serum Standard、MR Urine Standard、MR Urine Quality Control
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Prealbumin Kit (Turbidimetry Method)、Prealbumin Calibrator
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices
CO2 and TBA Multi Control
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device
Cystatin C Kit (Latex Immunoturbidimetric Method) 、Cystatin C Calibrator、Cystatin C Control
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·5 devices
Cholinesterase (CHE) Kit (DGKC Method)
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Lipids Calibrator
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device
β-Hydroxybutyrate Kit (Enzymatic Colorimetric Method)、β-HB Calibrator、β-HB Control
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·5 devices