하이로닉 인터내셔널 웹사이트로 이동합니다.
인터내셔널 웹사이트에는 수출용 제품으로 대한민국에서 허가하지 않은 장비 및 서비스 내용을 포함하고 있습니다. 해당 내용은 대한민국의 의료기기 광고 심의, 규제를 받지 않습니다.
It goes to the HIRONIC INTL. website.
The Intrrnation Web Site contains equipment and services that are not authorized by the Republic of Korea These contents are not subject to review and regulation of medical devices in Korea.
하이로닉 US 웹사이트로 이동합니다.
US 웹사이트의 내용은 "FDA"로 부터 허가승인된 품목의 제품 정보에 관한 것으로, 대한민국의 소비자 보호를 위한 국내법 의료기기의 광고 심의, 규제를 받지 않습니다.
It goes to the HIRONIC US website.
The contents of the US web page are about product information of items approved for "FDA". They are not subject to advertising deliberation and regulation of domestic law medical devices for consumer protection in Korea.
하이로닉 EU 웹사이트로 이동합니다.
EU 웹사이트의 내용은 "CE MDD 또는 CE MDR"로 부터 허가승인된 품목의 제품 정보에 관한 것으로, 대한민국의 소비자 보호를 위한 국내법 의료기기의 광고 심의, 규제를 받지 않습니다.
It goes to the HIRONIC EU website.
The contents of the EU(European) web page are about product information of items approved for "CEMDD or CEMDR" in EU countries. They are not subject to advertising deliberation and regulation of domestic law medical devices for consumer protection in Korea.
[Translate] Medical esthetic specialist HIRONIC Inc. announced in April that it has received the European CE MDD certification for its focused ultrasound medical device "Ultra Vera".
A HIRONIC official said, "CE MDD certification has been flooded with requests for orders from European countries such as Germany, France, Greece, and Luxembrook. Based on the technical capabilities verified through this certification , Asia, the Middle East and other countries, we have prepared a foothold to expand exports globally. "" We will do our best to develop the best products that can strengthen our competitiveness in the global market I want to. "
CE MDD (Medical Devices Directive) is a certification that must be acquired in order to enter the European Union market, which means that the quality and safety of hyronic products have been recognized at an international level. HIRONIC has already been CE MDD certified for Double 3 models (Doublo, Doublo S, Doublo Gold) and Mi cool S.
HIRONIC has been able to accelerate overseas business expansion by obtaining CE MDD certification for "Ultra Vera," which is the fourth model in the doublo series. "Ultra Vela" is a medical device, and is an upgraded version of a dual gold model with a cylindrical hand piece for Ultra Vera.
A HIRONIC official said, "CE MDD certification has been flooded with requests for orders from European countries such as Germany, France, Greece, and Luxembrook. Based on the technical capabilities verified through this certification , Asia, the Middle East and other countries, we have prepared a foothold to expand exports globally. "" We will do our best to develop the best products that can strengthen our competitiveness in the global market I want to. "
