A Korean Co2 laser system manufacturer, SNJ, enters Europe with CE certification SNJ successfully acquiring European CE certification with the support of KTL
Nov 03, 2020, 02:02
A Korean laser system manufacturer, SNJ, announced that it has successfully obtained the European CE certification for the surgical laser device through the government’s “Smart Healthcare Comprehensive Support Center Construction Project” supported by the Korea Testing and Technology Laboratory (KTL).
Domestic medical device manufacturers have suffered a lot of difficulties in obtaining European CE certification due to lack of certification information, long-term requirements, high overseas examination costs, and difficulties in foreign language communication.
KTL has been striving to relieve the inconveniences and difficulties experienced by domestic medical device manufacturers by actively providing on-site services such as support for on-site inspection, preparation of technical documents, and support for overseas certification examination costs. As a result, SNJ has acquired the European CE for the surgical laser device.
Meanwhile, as the European CE certification system for medical devices has been reinforced from the existing Medical Device Directive (MDD) to the Medical Devices Act (MDR) from May, '21, the European certification institution's clinical evaluation, technical document review, follow-up management and supervision, etc. International demand is expected to increase.
Based on the achievements of this European CE certification, KTL provides services such as customized licensing coaching for each manufacturer to acquire overseas certification, on-site review support, preliminary review of technical documents, and utilization of government overseas certification review cost support projects. It plans to respond to the European CE certification demand of manufacturing companies and make more efforts to enhance the export competitiveness of products.
CEO Chang Tae Hee of SNJ said, “The European CE certification acquired through the ‘Smart Healthcare Comprehensive Support Center Construction Project' with the support of KTL is the most essential factor for entering Europe. In addition, it may take a long time to obtain a certification, and it may have a lot of difficulty, but this project has provided a foothold finally to reach Europe by obtaining it without much difficulty. In the future, we will make ceaseless efforts to enter Europe in earnest, and we will promote our products more through various and aggressive marketing.”
Meanwhile, SNJ, established in 1998, has been specializing in medical laser systems after being certified as a KFDA medical equipment manufacturer in 1999. Products are exported to many countries around the world, and the CO2 laser system developed with a focus on ultra pulse technology over the past 19 years is receiving good reviews from overseas hospitals and doctors. SNJ aims to become a powerful global company providing medical and cosmetic solutions through small but high-quality laser technology and production experience.
For more information on SNJ and the Shopping Mall, visit http://www.aestheticsnjmall.com/.
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Written by Hanmir PRNews
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