CE 0197 is a medical grade certification used by the European community, analogous to FDA certification in the United States.
The CE marking, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard or directive. “EC” refers to the European Community. Translated from French, it literally means European Community. The European Commission, which administers the scheme, describes the CE marking as a “passport” for goods that can be sold freely on the European internal market. It is required by law if the product falls under one of the “new approach” directives. It is not a quality brand, nor a brand for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product complies with the “New Approach” directives. All manufacturers are required to affix the CE mark on products covered by the New Approach Directives. The CE marking on a product indicates to all authorities that the product complies with the essential health and safety requirements of all directives that apply to the product.