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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 SS-A/Ro
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
IDS dsDNA IgG
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
IDS ENA Screen
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
IDS-iSYS 17-OH Progesterone
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·2 devices
IDS-iSYS Free Testosterone
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·2 devices
POConePlus Infrared Spectrophotometer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Otsuka Electronics Co., Ltd.·1 device
CHOLESTEROL
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Medicon Hellas SA·4 devices
1,25-Dihydroxy Vitamin D EIA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
25-Hydroxy Vitamin DS EIA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
N-MID® Osteocalcin ELISA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device