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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.
RIDA®GENE Parasitic Stool Panel I
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·R-Biopharm AG·3 devices
RIDASCREEN® Clostridium difficile Toxin A/B
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·R-Biopharm AG·5 devices
RIDASCREEN® Clostridium difficile GDH
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·R-Biopharm AG·5 devices
25-OH-VD (CLIA)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Sophonix Co., Ltd.·1 device
Serotonin Urine ELISA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·1 device
Melatonin-Sulfate Urine ELISA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·1 device
ASO
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Medicon Hellas SA·5 devices
ALT/GPT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Medicon Hellas SA·5 devices
ACE
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Medicon Hellas SA·7 devices
ISE Low Serum Standard
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Ireland Inc.·1 device