求翻译：美国是在产品上市前的注册方面比较严格，因此本文在对510（k）方面，进行着重介绍。而欧盟主要是对产品的CE认证方面把关较为严格，本文就针对类医疗器械CE认证进行了详细的叙述是什么意思？

The United States is more stringent in the 510 (k), highlights the products to market before the registration. The European Union is mainly ce certification of products to ensure more stringent for Class I medical devices ce certification described in detail

The United States is in the product listing in the registry, and therefore this is strictly in the 510 (K) and to focus on. And from the EU is the main product of CE certification are more stringent, guarding against this type of medical equipment CE certification described in detail

US is quite is strict before the product going on the market registration aspect, therefore this article in to 510(k) aspect, carries on introduced emphatically.But European Union mainly is checks to the product CE authentication aspect strictly, this article aimed at the kind of medical instrument

United States are listed on the product register aspects before more stringent, so this article 510 (k), focuses on. Mainly on the European Union CE certification checks more strict, this article is more for medical devices CE certification description

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