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19.12.2024
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Urgent Field Safety Notice for THUNDERBEAT by Olympus Medical Systems Corp.
Product group Ultrasonics -
ultrasonic therapeutic equipment
Reference 44530/24
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18.12.2024
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Urgent Field Safety Notice for Single Use Mechanical Lithotriptor V by Olympus Medical Systems Corp.
Product group Optics / Precision engineering -
precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 44292/24
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18.12.2024
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Urgent Field Safety Notice for DeepUnity Viewer 2.x by DH Healthcare GmbH
Product group Radiological technology -
auxiliary equipment and supplies for radiology / nuclear medicine
Reference 43147/24
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17.12.2024
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Urgent Field Safety Notice for Centricity PACS by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc
Product group Radiological technology -
auxiliary equipment and supplies for radiology / nuclear medicine
Reference 30752/24
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17.12.2024
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Urgent Field Safety Notice for Blutkultur-Adapter by Sarstedt AG & Co
Product group In-vitro diagnostics -
instruments, apparatuses and systems
Reference 43272/24
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17.12.2024
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Study submission and user account
Study Submission and User Account
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17.12.2024
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New information regarding allocation of DCP slots
Update on allocation of DCP slots
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16.12.2024
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Iris and ICD-11
Iris and ICD-11
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16.12.2024
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Iris - Reported issues by users with answers from Iris Core Group
Iris - Reported issues by users with answers from Iris Core Group
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16.12.2024
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Urgent Field Safety Notice for DLP One-Piece Pediatric Arterial Cannula 8 Fr. DLP One-Piece Pediatric Arterial Cannula 14 Fr. EOPA - Elongated One Piece Arterial Cannula 18 Fr.; EOPA - Elongated One Piece Arterial Cannula 22 Fr.; Select Series Angled Tip Arter by Medtronic Inc
Product group Injections / Infusions / Transfusions / Dialysis -
syringes and cannulas
Reference 43678/24
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16.12.2024
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Urgent Field Safety Notice for MEDRAD Centargo by Imaxeon Pty Ltd Imaxeon is a subsidiary company of Bayer
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 43923/24
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16.12.2024
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Urgent Field Safety Notice for Glucose Liquicolor by HUMAN Gesellschaft für Biochemica und Diagnostica mbH
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 42662/24
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16.12.2024
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Urgent Field Safety Notice for CGM CLINICAL Medication by CompuGroup Medical Deutschland AG
Product group Medical data processing (software) -
others
Reference 43110/24
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16.12.2024
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Urgent Field Safety Notice for diverse by Coloplast A/S
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 42731/24
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16.12.2024
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Urgent Field Safety Notice for Trilogy Evo, Trilogy Evo O2, Trilogy EV300 by Respironics, Inc. Pittsburgh
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 32707/24
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16.12.2024
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New version of Iris version 6 is available for testing with ICD-11
The second test version of Iris version 6 for ICD-11 mortality coding has been released. You will find version 6.0.26 and the Iris Manual under “Downloads” on our website.
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16.12.2024
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DRKS online help - authenticated area - Instruction DRKS application (study administration)
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13.12.2024
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Urgent Field Safety Notice for DeepUnity Viewer 2.x by DH Healthcare GmbH
Product group Radiological technology -
auxiliary equipment and supplies for radiology / nuclear medicine
Reference 43157/24
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12.12.2024
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Written renouncement
As of 12.12.2024 online procedures für „Renouncement declarations in accordance with Section 31 sub-section 1 sentence 1 number 2 AMG in conjunction with Section 29 sub-section 1g AMG (Medicinal Products Act)“ and „Declarations of the reasons for the non-submission of an application for renewal in accordance with Section 29 sub-section 1g AMG (Medicines Products Act)“ are availabe via the portal PharmNet.Bund.
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12.12.2024
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Notification obligations of the marketing authorisation holder in accordance with Section 29 sub-section 1g AMG as of 28 October 2013
As of 12.12.2024 online procedures für „Renouncement declarations in accordance with Section 31 sub-section 1 sentence 1 number 2 AMG in conjunction with Section 29 sub-section 1g AMG (Medicinal Products Act)“ and „Declarations of the reasons for the non-submission of an application for renewal in accordance with Section 29 sub-section 1g AMG (Medicines Products Act)“ are availabe via the portal PharmNet.Bund.
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