求翻译：本文主要以美国和欧盟的法律条例介绍为例，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，则针对类医疗器械CE认证进行了详细的叙述是什么意思？

In this paper, for example, the U.S. and EU laws and regulations about the United States is more stringent in the products to market before the registration, in the 510 (k) highlights. The EU's main product ce certification checks are more stringent, ce certification for Class I medical devices desc

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This article mainly take American and European Union's legal rule introduction as the example, 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 p

This article mainly in the United States and the European Union's introduction of laws and regulations, for example, 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,

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