Ce Marking

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Abbott's Amplatzer Piccolo™ Delivery System Receives FDA Clearance and CE Mark to Optimize Procedures for ...

Winona Daily News 19 Dec 2025

First and only delivery system designed specifically for ...

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Abbott's Amplatzer Piccolo™ Delivery System Receives FDA Clearance and CE Mark to Optimize Procedures for Premature Babies With a Hole in the Heart

PR Newswire 18 Dec 2025

Food and Drug Administration (FDA) clearance and CE Mark for its Amplatzer Piccolo™ Delivery System, which is used with the company's Amplatzer Piccolo Occluder ... FDA approval and CE Mark in 2019.

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May Health Announces CE Mark for Innovative Treatment for Women with PCOS-related Infertility

Business Wire 16 Dec 2025

... technology to treat PCOS-related infertility, the Anavi™ System, has received CE Mark certification.

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Lords Mark Industries Ltd.–Renalyx approved to manufacture Class C AI-based haemodialysis machines; earns global CE marking

The Economic Times 15 Dec 2025

This innovation, also CE-marked, signifies a global leap in advanced ...

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AZmed Expands Into CT Imaging With CE-Marked AZnod, An AI Tool for Lung Nodule Detection and the First Product in the Rayscan® Line

PR Newswire 15 Dec 2025

Its Rayvolve® AI Suite includes FDA-cleared and CE-marked tools, while its Rayscan® line is CE-marked.

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Roche expands automated mass spectrometry menu with antibiotics drug monitoring CE mark approval offering industry’s ...

Nasdaq Globe Newswire 11 Dec 2025

RHHBY) announced today that it has secured CE Mark approval for its mass ...

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VALVOSOFT®, the First Non-Invasive Treatment for Severe Symptomatic Aortic Stenosis (sSAS) from Cardiawave Receives CE Marking

Business Wire 05 Dec 2025

LEVALLOIS-PERRET, France--(BUSINESS WIRE)-- #AorticStenosis--Cardiawave, a pioneering medtech company ...

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New revisions of regulations for certifications in the field of CE marking for construction products: effective from 1 december 2025 (RINA SpA)

Public Technologies 04 Dec 2025

- Regulation for the issuance of certification of conformity of factory production control (FPC) pursuant to Regulation (EU) no. 305/2011 relating to construction products. [...] ... Disclaimer ... (noodl.

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Dicom Systems Processes 124 Billion Medical Images Annually and Achieves ISO 27001 Certification, CE Mark, Expands Digital Pathology and Reseller Partnerships

PR Newswire 03 Dec 2025

Alongside this growth, Dicom Systems achieved ISO/IEC 27001 and CE Mark certifications in 2025, demonstrating its commitment to global standards for information security, product quality, and regulatory compliance.

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Roche receives FDA clearance with CLIA waiver and CE Mark for its first point-of-care test ...

Nasdaq Globe Newswire 02 Dec 2025

Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, in addition to CE IVDR certification ... .

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MediView Achieves First CE Mark, Bringing Augmented Reality to European Healthcare

PR Newswire 01 Dec 2025

The CE mark validates ... This CE mark is a testament to the incredible work of our team and MediView's vision to usher in a new era of image-guided interventions," said Mina Fahim, CEO of MediView.

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GE HealthCare announces CE Mark for the Omni 128cm total body PET/CT system (GE HealthCare Technologies Inc)

Public Technologies 28 Nov 2025

). The text version of this document is not available ... Disclaimer ... (noodl. 128027494) .

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GE HealthCare announces CE Mark for new digital 4D SPECT/CT system, StarGuide GX (GE HealthCare Technologies Inc)

Public Technologies 27 Nov 2025

). The text version of this document is not available ... Disclaimer ... (noodl. 128004087) .

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One year on: EU Batteries Regulation and CE marking impacting energy storage systems

Energy Storage News 20 Nov 2025

A year since the implementation of the initial steps in EU Batteries Regulation went into effect and the impacts are already being seen, writes Nicholas Bellini of T�V S�D ....

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Overture Life Receives CE Mark Approval to Commercialize Fertility Automation in Europe

Business Wire 20 Nov 2025

MADRID & PALO ALTO, Calif.--(BUSINESS WIRE)--Overture Life, the global leader in automated IVF and ...

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Latest News for: ce marking

Abbott's Amplatzer Piccolo™ Delivery System Receives FDA Clearance and CE Mark to Optimize Procedures for ...

Abbott's Amplatzer Piccolo™ Delivery System Receives FDA Clearance and CE Mark to Optimize Procedures for Premature Babies With a Hole in the Heart

May Health Announces CE Mark for Innovative Treatment for Women with PCOS-related Infertility

Lords Mark Industries Ltd.–Renalyx approved to manufacture Class C AI-based haemodialysis machines; earns global CE marking

AZmed Expands Into CT Imaging With CE-Marked AZnod, An AI Tool for Lung Nodule Detection and the First Product in the Rayscan® Line

Roche expands automated mass spectrometry menu with antibiotics drug monitoring CE mark approval offering industry’s ...

VALVOSOFT®, the First Non-Invasive Treatment for Severe Symptomatic Aortic Stenosis (sSAS) from Cardiawave Receives CE Marking

New revisions of regulations for certifications in the field of CE marking for construction products: effective from 1 december 2025 (RINA SpA)

Dicom Systems Processes 124 Billion Medical Images Annually and Achieves ISO 27001 Certification, CE Mark, Expands Digital Pathology and Reseller Partnerships

Roche receives FDA clearance with CLIA waiver and CE Mark for its first point-of-care test ...

MediView Achieves First CE Mark, Bringing Augmented Reality to European Healthcare

GE HealthCare announces CE Mark for the Omni 128cm total body PET/CT system (GE HealthCare Technologies Inc)

GE HealthCare announces CE Mark for new digital 4D SPECT/CT system, StarGuide GX (GE HealthCare Technologies Inc)

One year on: EU Batteries Regulation and CE marking impacting energy storage systems

Overture Life Receives CE Mark Approval to Commercialize Fertility Automation in Europe

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