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EU MDR Class IIb Software Devices

View 130 EU MDR Class IIb software devices on BEUDAMED, the Better Database on Medical Devices. Class IIb software devices are higher-risk medical software under the EU MDR that can drive diagnosis, therapy or monitoring and typically require conformity assessment by a notified body. Use the database to find device identifiers, manufacturer details, and declared regulatory status to support procurement and compliance checks.

EU MDR Class IIb software devices must meet stringent requirements for technical documentation, clinical evaluation, risk management, and cybersecurity measures. Manufacturers are required to demonstrate performance through clinical evidence, maintain robust post-market surveillance and vigilance reporting, and apply UDI and labeling consistent with EU MDR rules. These measures help protect patient safety while enabling innovation in medical software.

ANTERION Software

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Heidelberg Engineering GmbH·1 device

Radiology Operations Command Center Console

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Philips Medical Systems Nederland B.V.·1 device

HCAlert

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Hope Care SA·1 device

Clinical Information System FONS Enterprise

Basic UDI-DI
EU MDR · Eu Md Class 2b ·STAPRO s. r. o. ·1 device

Cranial Navigation

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Brainlab AG·1 device

ChestLink

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Oxipit, UAB·1 device

CT ASPECT Scoring

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Philips Medical Systems Nederland B.V.·1 device

Human Smart Safe Therapy

Basic UDI-DI
EU MDR · Eu Md Class 2b ·BIMIND SRL·2 devices

Merlot Medi Physio

Basic UDI-DI
EU MDR · Eu Md Class 2b ·CGI Suomi Oy·1 device

NX Software

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Agfa NV·2 devices