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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.
MuSK-Ab ELISA
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·IBL International GmbH·1 device
IDS-iSYS ACTH N
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Immunodiagnostic Systems Limited·3 devices
RIDA®UNITY Norovirus I & II
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·R-Biopharm AG·1 device
TOTAL PROTEIN
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Medicon Hellas SA·6 devices
GGT
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Medicon Hellas SA·4 devices
RealAccurate® Quadruplex Influenza PCR Kit
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·PathoFinder B.V.·1 device
NutriDetect™ 7G A ELISA
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Biomerica, Inc.·1 device
RIDA®GENE Helicobacter pylori
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·R-Biopharm AG·3 devices
IDS Calprotectin
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Immunodiagnostic Systems Limited·4 devices
Rheumatoid Factor Kit (Particle-enhanced Immunoturbidimetric Assay Method)、Rheumatoid Factor Calibrator
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·5 devices