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.
ACTIVE® Renin IRMA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH s.r.o.·1 device
ACTIVE® PTHrP IRMA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH s.r.o.·1 device
Anti-TPO RIA KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH s.r.o.·1 device
Ostase IRMA KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH s.r.o.·1 device
T3 Uptake RIA KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH s.r.o.·1 device
IRMA IGF-I
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH s.r.o.·1 device
TSH IRMA KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH s.r.o.·2 devices
Total T3 RIA KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH s.r.o.·2 devices
RIA FT3
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH s.r.o.·2 devices
FT4 RIA KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IMMUNOTECH s.r.o.·2 devices