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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-iSYS Aldosterone
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·2 devices
Immunochemistry Systems UCAL Urine Protein Calibrator
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Beckman Coulter Inc.·1 device
IDS-iSYS N-MID® Osteocalcin
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Immunodiagnostic Systems Limited·2 devices
Gentian Calprotectin Reagent Kit
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Gentian AS·4 devices
GCAL®NEPH Calprotectin
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Gentian AS·3 devices
IDS-iSYS Ostase® BAP
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Immunodiagnostic Systems Limited·2 devices
IDS-iSYS 25 VitDS
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Immunodiagnostic Systems Limited·3 devices
IDS-iSYS 1,25-Dihydroxy Vitamin D
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Immunodiagnostic Systems Limited·2 devices
Urine CrossLaps® (CTX-I) EIA
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
Serum CrossLaps® (CTX-I) ELISA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device