Tele: 561.316.3330
Breaking Medical Device News

Wednesday, September 22, 2021
HomeMosaic Surgical Ltd.Mosaic Surgical Launches New Fixed Fee Service to Support Post-Brexit UKCA Marking

Mosaic Surgical Launches New Fixed Fee Service to Support Post-Brexit UKCA Marking

February 11, 2021

Mosaic Surgical Ltd is based in High Wycombe, UK.

Today the company announced a new fixed-fee service for UKCA marking with a UK notified body that will support manufacturers and distributors of surgical products that previously traded under EU law and CE marking before Brexit, and help to ensure continuity of production, conformity with sales legislation and, crucially, uninterrupted trade in the UK.

New legislation for marketing products in the UK came into force on January the 1st 2021, stipulating that most goods previously subject to the CE marking must now comply with and display UKCA marking instead.

The County Mayo-based company Idoman Teoranta was the first to recognise the value of Mosaic Surgical’s newly launched service, and has already entered into an agreement to deliver UKCA marking for its Thermablate EAS™, a handheld automated device for treatment of heavy menstrual bleeding.

Manufactured by Idoman and distributed by JUNE Medical, Thermablate EAS offers fast, safe and effective ablation treatment in just three minutes. Under the agreement, Mosaic Surgical will assume the role of the UK Responsible Person, providing a cost-effective route to UKCA marking. Other well-known companies that have also engaged Mosaic Surgical as their UK representative include Synergo Medical and Neomedic.

Emma Maidwell, Managing Director of JUNE Medical, commented: “As the distributor for Thermablate EAS, we are delighted to see that Mosaic Surgical, a reputable and knowledgeable company, is to become the UK Responsible Person for this product, smoothing the transition to UKCA marking.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System

The system maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning, and grafting process for TLIF and PLIF spinal fusion procedures.

Matthew Cranfill New ExtriCARE USA Director Of Clinical Services

"Matt's impressive experience and skillset easily made him our top pick," said Peter Mason, President of ExtriCARE USA.

FDA Authorizes Software that Can Help Identify Prostate Cancer

The software is called Paige Prostate and is compatible for use with slide images that have been digitized using a scanner.

Shannon Lantzy MedCrypt New VP of Consulting

"I met Shannon at a healthcare-related event several years ago and was immediately impressed with her passion and drive to move healthcare into a digital future," said Mike Kijewski, CEO of MedCrypt.

Mark Foster Joins Xenocor BOD

Foster is a versatile and visionary C-Suite executive who brings 20 years of general management and leadership experience from both venture-backed growth-stage organizations and world-class medical device companies

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

Rhaeos Awarded $4 Million NIH SBIR Grant

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric.

By using this website you agree to accept Medical Device News Magazine Privacy Policy