SEO landing
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.
ISE High Serum Standard
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·1 device
ISE Internal Reference
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·1 device
ISE Low/High Urine Standard
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·1 device
Immunochemistry Systems Level 2 Urine Protein Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·1 device
Immunochemistry Systems Level 1 Urine Protein Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·1 device
IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·1 device
IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·1 device
IMMAGE Immunochemistry Systems ASO Anti-Streptolysin O Reagent
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·1 device
IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·1 device
IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·1 device