Latest News for: ce marking

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Vietnam’s GCDRI Strengthens Business Support in ISO, FDA, and CE Marking Consulting

GetNews 19 Mar 2026
Corporate image representing Global Certification Development Research Institute (GCDRI) delivering ISO certification consulting, FDA registration support, and CE Marking advisory services for manufacturers, exporters, and businesses in Vietnam.
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Fujirebio Announces CE Marking of the Fully Automated Lumipulse® G Nfl Blood Assay

Business Wire 17 Mar 2026
has obtained a CE Certificate of the Lumipulse G NfL Blood assay under the Regulation (EU) 2017/746 ...
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Fujirebio Announces CE Marking of the Fully Automated Lumipulse� G Nfl Blood Assay

Business Wire 17 Mar 2026
has obtained a CE ... our first CE-marked blood test that empowers clinicians with insights across a wide range of neurological disorders,” said Christiaan De Wilde, CEO at Fujirebio Europe N.V.
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Roche receives CE mark for first IVD immunoassay blood test to identify carriers of ApoE4, a genetic variant present in up to 60% of patients diagnosed with Alzheimer's disease

PR Newswire 16 Mar 2026
The Elecsys ApoE4 test is the first CE marked in-vitro diagnostic immunoassay to identify individuals carrying the ApoE4 genetic variant using a simple blood sample ... Building on the recent CE mark ...
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MiniMed expands sensor portfolio in Europe with CE Mark for MiniMed™ 780G system with the Instinct sensor, made by Abbott

PR Newswire 10 Mar 2026
(MiniMed), a global leader in full stack insulin delivery, today announced CE (Conformité Européenne) Mark for use of the MiniMed™ 780G system with the Instinct sensor, made by Abbott ... The system is also CE Marked in Europe for use during pregnancy.
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DeepHealth Achieves CE Mark for TechLive™ and Enables AWS Marketplace Deployment, Advancing Global Expansion of ...

Nasdaq Globe Newswire 26 Feb 2026
DeepHealth's TechLive remote scanning solution achieves CE marking for Europe, accelerated commercial traction in the U.S. and AWS Marketplace availability ... .
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Polaroid Therapeutics (PTx) Receives CE Mark for POLTX_Fiber™: the first application of APT™ to launch ...

Canada Newswire 25 Feb 2026
25, 2026 /CNW/ -- Polaroid Therapeutics (PTx) today announces that POLTX_Fiber™ has received the CE Mark as a Class IIb medical device with APT™ (Antimicrobial Polymer Technology). .
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Polaroid Therapeutics (PTx) Receives CE Mark for POLTX_Fiber™: the first application of APT™ to launch a new standard in wound care

PR Newswire 25 Feb 2026
25, 2026 /PRNewswire/ -- Polaroid Therapeutics (PTx) today announces that POLTX_Fiber™ has received the CE Mark as a Class IIb medical device with APT™ (Antimicrobial Polymer Technology). .
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MHRA launches a consultation on indefinite recognition of CE-marked medical devices (MHRA - Medicines and Healthcare products Regulatory Agency)

Public Technologies 16 Feb 2026
The proposals extend measures put in place in 2023 to recognise CE marked medical devices on the GB market up to 2030 - Timeframe for accepting CE marked medical devices in Great Britain extended - GOV.UK.
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Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices (MHRA - Medicines and Healthcare products Regulatory Agency)

Public Technologies 16 Feb 2026
). The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on proposals for the approach to recognising CE marked medical devices in Great Britain ... Attachments Original document Permalink.
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