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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.
IDS Cardiolipin IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
IDS t-TG IgA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
IDS Deamidated Gliadin IgA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
Access TSH (3rd IS)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH SAS ·2 devices
Access TSH (3rd IS) Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH SAS ·1 device
IDS Anti-TG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
IDS Liver Control Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
IDS GBM
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
IDS APS IgM Control Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
IDS t-TG IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device