李国杰（经理）：18202125732
1、出口企业的经营范围里需要有进出口与销售二类***器械的范围；
2、出口企业需要具备进出口权资质【包括对外贸易登记、海关注册、电子口岸备案与外管局备案手续】；
3、如出口***类口罩，因***类口罩属于二类***器械，出口企业需要具备二类***器械经营备案资质。
1. The business scope of the export enterprise shall include the scope of import, export and sales of class II medical devices;
2. Export enterprises need to h***e the qualification of import and export right [including foreign trade registration, customs registration, E-port filing and the filing procedures of safe];
3. For example, for the export of medical masks, because the medical masks belong to class II medical devices, the export enterprises need to h***e class II medical device business filing qualification.
李国杰（经理）：18202125732
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