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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.
Ostase® BAP EIA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
Urine CartiLaps® (CTX-II) EIA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
Urine BETA CrossLaps® (CTX-I) ELISA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
Alpha CrossLaps® (CTX-I) ELISA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
Creatinine Enzymatic
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Instrumentation Laboratory SpA·1 device
BoneTRAP® (TRAcP 5b) ELISA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) IRMA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
Total Immunoglobulin E (IgE)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·1 device
DRI Opiate
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Instrumentation Laboratory SpA·1 device
IDS ANCA/GBM Control Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device