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23.06.2025
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Structure of the BfArM in text form
Structure
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04.07.2025
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Submission of Variations
Aerosol dispensers containing fluorinated greenhouse gases, including medicinal metered dose inhalers, may only be placed on the market, supplied or made available to third parties in the EU from 1 January 2025 if they are labelled in accordance with Article 12(3) of Regulation (EU) 2024/573 on fluorinated greenhouse gases (F-Gas Regulation).
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30.01.2025
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Urgent Field Safety Notice for 2.0/2.3 TriLock Plate MC I Base, t1.0 by Medartis AG
Product group Non-active implants -
bone surgery
Reference 02738/25
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16.05.2025
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Urgent Field Safety Notice for 3M Ranger Blood/Fluid Warming System, 3M Ranger Irrigation Fluid Warming System by 3M Company
Product group Injections / Infusions / Transfusions / Dialysis -
equipment for collecting blood products and peripheral stem cells
Reference 17828/25
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08.07.2025
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Urgent Field Safety Notice for 3mensio Workstation by Pie Medical Imaging B.V.
Product group Medical data processing (software) -
software for computer-based treatment
Reference 28334/25
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10.04.2025
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Urgent Field Safety Notice for 4008 S V10 and spare parts Solenoid valve V84 by Fresenius Medical Care AG & Co. KGaA
Product group Injections / Infusions / Transfusions / Dialysis -
dialysis technology
Reference 13406/25
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16.01.2025
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Urgent Field Safety Notice for 4008H, B, S. Art. Prometheus by Fresenius Medical Care AG & Co. KGaA
Product group Injections / Infusions / Transfusions / Dialysis -
dialysis technology
Reference 45042/24
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13.03.2025
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Urgent Field Safety Notice for 4Fr Single-Lumen PowerPICC Catheter (SOLO and no.-SOLO) by Bard Access Systems Division (BASD)
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 09010/25
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22.05.2025
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Urgent Field Safety Notice for 4Fr Single-Lumen PowerPICC Catheter (SOLO and no.-SOLO) by Bard Access Systems Division (BASD)
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 19743/25
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18.06.2025
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Urgent Field Safety Notice for 8-402 Atemtraining-Set by Flexicare Medical Limited
Product group Physical therapy -
insufflation technique
Reference 21354/25
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19.03.2025
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Urgent Field Safety Notice for ABL90 FLEX and ABL90 PLUS by Radiometer Medical ApS
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 08632/25
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18.02.2025
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Urgent Field Safety Notice for Access 2 Immunoassay System by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 04850/25
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10.04.2025
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Urgent Field Safety Notice for Access EPO Reagent by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 05161/25
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07.01.2025
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Urgent Field Safety Notice for Access High Sensitivity Troponin I Reagent by Beckman Coulter Inc.
Product group In-vitro diagnostics -
immunological products
Reference 41368/24
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19.03.2025
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Urgent Field Safety Notice for Access Vitamin B12 Reagent by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 08374/25
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08.07.2025
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Urgent Field Safety Notice for Achieva 3.0T/XR, Evolution upgrade 1.5T/3.0T, Ingenia 1.5T/1.5T S/3.0T/3.0T CX/Ambition S/Ambition X/Elition S/Elition X/Intera 3.0T Quasar Dual, MR 5300, MR 7700, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0 by Philips Medical Systems Nederland B.V.
Product group Electromedical fields -
equipment for MR tomography
Reference 28689/25
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28.01.2025
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Urgent Field Safety Notice for Achieva TX Interventional Coil 3.0T, dS Breast 16c by PHILIPS HEALTHCARE FRANCE
Product group Electromedical fields -
equipment for MR tomography
Reference 38752/24
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01.07.2025
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Urgent Field Safety Notice for ACL TOP 970 CL by Instrumentation Laboratory Co.
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 27696/25
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06.03.2025
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Urgent Field Safety Notice for Acrobat-i and Acrobat SUV Stabilizer/Positioner by Maquet Cardiovascular
Product group Medical instruments for use in humans -
cardiac/thorax surgery
Reference 39138/24
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04.06.2025
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Urgent Field Safety Notice for Acurate neo2 and Prime Aortic Valve System by Boston Scientific Corporation Marlborough
Product group Non-active implants -
cardiac surgery
Reference 38522A/24
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