CE & FDA certification

MegaGen Implant uses various methods to guarantee and improve quality and safety.

MegaGen Implant products are produced under the strictest possible conditions. And meet all the requirements set for this.

The products we manufacture meet the highest standards: and are CE approved and FDA approved. In addition, because MegaGen Implant is a South Korean company, all products meet all the requirements of the Korean Food and Drug Administration (KFDA), which is known for possibly the most consistent guidelines in the world. This means that not only safety is guaranteed, but that there is sound scientific substantiation of the application of our products.

MegaGen Implant continuously strives to deliver high-quality and safe products.

MegaGen-CE-FDA-certification

CE – This marking is not a mark, but a marking affixed by the manufacturer or his authorised representative. The marking guarantees that the product meets the requirements of the European related directives.

FDA – The Food and Drug Administration is an agency of the federal government in the United States, which, among other things, monitors the quality and safety of food and related matters. Rubbers, gaskets and elastomers in general with the FDA food label are suitable for applications in the food and pharmaceutical industries.

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Quality documents MegaGen

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