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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.
5’-Nucleotidase Kit (Enzymatic Colorimetric Method)、5’-NT Control、5’-NT Calibrator
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·8 devices
Retinol Binding Protein Kit (Particle-enhanced Immunoturbidimetric Assay Method)、RBP Calibrator、RBP Control
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·8 devices
Angiotensin Converting Enzyme Kit (Enzymatic Colorimetric Assay Method)、ACE Calibrator、 ACE Control
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·8 devices
IRON
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Medicon Hellas SA·6 devices
IGM
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Medicon Hellas SA·4 devices
IGG
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Medicon Hellas SA·4 devices
AutoLumo analyzer
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·1 device
RIDA®CHIP FoodGuide
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·R-Biopharm AG·3 devices
AST/GOT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Medicon Hellas SA·5 devices
Urine DoA Cannabinoid Calibrators
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Instrumentation Laboratory SpA·1 device