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08.04.2025
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Urgent Field Safety Notice for Silicone oil by DORC Dutch Ophthalmic Research Center (International) BV
Product group ophthalmological technology -
equipment for ophthalmological therapeutics
Reference 35536/24
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07.04.2025
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Urgent Field Safety Notice for Atellica CH Diluent by Siemens Healthcare Diagnostics Inc. Tarrytown
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 05549/25
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07.04.2025
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Urgent Field Safety Notice for Stratus CS Acute Care cTNI TestPak by Siemens Healthcare Diagnostics Inc. Newark
Product group In-vitro diagnostics -
immunological products
Reference 13140/25
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07.04.2025
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Urgent Field Safety Notice for Giraffe Omnibed and Giraffe Incubator; Giraffe Warmer, Panda i.e. Warmer by Datex-Ohmeda, Inc
Product group Physical therapy -
climatotherapy
Reference 35474/24
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04.04.2025
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Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)
Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)
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04.04.2025
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DACO HealthData Insights
With the free newsletter, we keep you updated on the progress in establishing DACO and the developments in the secondary data use sector of the EHDS.
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04.04.2025
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Statistics "Complementary and Alternative Medicines (CAM) and Traditional Medicinal Products (TMP)"
The following table gives an overview of the herbal, homeopathic and anthroposophic medicinal products with completed marketing authorisation or registration procedure which are available on the German market.
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03.04.2025
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Urgent Field Safety Notice for Coloplast Drainage bag 1-piece open sterile by Coloplast A/S
Product group Orthopaedic / Rehabilitation technology -
care of natural and artificial body orifices
Reference 12860/25
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03.04.2025
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Urgent Field Safety Notice for Soluscope Serie 4 by Soluscope S.A.S.
Product group General equipment for medical treatment -
cleaning / disinfection / sterilisation
Reference 00742/25
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03.04.2025
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Urgent Field Safety Notice for Sophie 2020 by Fritz Stephan GmbH
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 11128/25
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03.04.2025
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Urgent Field Safety Notice for LinkSymphoKnee System, Femuraugment & Tibiaaugment by Waldemar Link GmbH & Co. KG
Product group Non-active implants -
bone surgery
Reference 11372/25
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02.04.2025
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Urgent Field Safety Notice for Gallensekretbeutel 1,5 L by Changzhou Hekang Medical Instruments Co., Ltd.
Product group Injections / Infusions / Transfusions / Dialysis -
drainages and suction systems
Reference 04031/24
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01.04.2025
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Urgent Field Safety Notice for Flexcel Carotid Shunt by LeMaitre Vascular, Inc.
Product group Non-active implants -
special implants
Reference 11607/25
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01.04.2025
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Urgent Field Safety Notice for DxC 500i Clinical Analyzer by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 11632/25
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01.04.2025
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Urgent Field Safety Notice for Sempermed Derma PF by Harps Investment Asia Pte Ltd
Product group General equipment for medical treatment -
auxiliary equipment
Reference 12267/25
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01.04.2025
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Variations
On the occasion of the new Variation Regulation (EC) No 1234/2008 which applies since 1 January 2010 a new web page "Variations" has been created and should be considered.
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31.03.2025
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Mysimba: potential long-term cardiovascular risk
Active substance: naltrexone, bupropion
EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), regarding the potential long-term cardiovascular risk (affecting the heart and blood circulation).
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31.03.2025
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Urgent Field Safety Notice for Perfusion solutions (PlegiStore, LungProtect, CelProtect, StoreProtect, StoreProtect Plus, PumpProtect, Belzer UW, Belzer MPS) by Carnamedica S.. z o.o.
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 10438/25
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31.03.2025
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Events and trainings
Events and trainings
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31.03.2025
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Save the date – next Iris webinar
The next Iris webinar will be held on 15th April 2025.
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