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Urgent Field Safety Notice for DR 800 by Agfa HealthCare N.V. PDF, 224KB, File does not meet accessibility standards Date: 19. December 2025 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 55491/25

Urgent Field Safety Notice for basixCOMPAK Inflation Device by Merit Medical Systems Inc. PDF, 270KB, File does not meet accessibility standards Date: 19. December 2025 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 56933/25

Urgent Field Safety Notice for cobas c 703 analytical unit by Roche Diagnostics GmbH PDF, 495KB, File does not meet accessibility standards Date: 19. December 2025 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 57337/25

Urgent Field Safety Notice for Automated Tube Sorter TS-10 by Sysmex Japan Corporation PDF, 878KB, File does not meet accessibility standards Date: 19. December 2025 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 58724/25

Urgent Field Safety Notice for Syringe 10ml L/L 3parts Red plunger, (TAVI Set, AnngioSet) by Mölnlycke Health Care AB (Molndal) PDF, 4MB, File does not meet accessibility standards Date: 19. December 2025 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 59615/25

Urgent Field Safety Notice for Microsensor /CereLink ICP sensor Basic kit by Integra LifeSciences Corp. PDF, 424KB, File does not meet accessibility standards Date: 19. December 2025 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 60424/25

Marketable medicinal products in the responsibility of the BfArM Date: 19. December 2025 Topics: Licensing Type: Article

On the following page you will find the figures of marketable medicinal products in the responsibility of the BfArM, broken down according to type of authorisation procedure as well as details of the authorisation status. The figures are …

Processing statistics Date: 19. December 2025 Topics: Licensing Type: Article

Here the BfArM publishes the current processing statistics of authorisations and registrations as well as of renewals. The figures are updated on a monthly basis.

Privacy policy Date: 19. December 2025 Topics: About BfArM Type: Article

Privacy policy

Notification of Medical Devices and In vitro Diagnostics Date: 18. December 2025 Type: Article

Medical devices and in vitro diagnostic devices as well as information on the PRRC have to be notified via DMIDS until 28 May 2026.