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《21 CFR 801 翻译稿中英文对照》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。
1、801.1Medicaldevices;nameandplaceofbusinessofmanufacturer,packerordistributor.医疗器械，制造商、包装商或分销商的经营名称和地址(a)Thelabelofadeviceinpackageformshallspecifyconspicuouslythenameandplaceofbusinessofthemanufacturer,packer,ordistributor.器械包装的标标识上应醒目地标明制造商、包装商或分销商的经营名称和地址。(b)(b)
2、Therequirementfordeclarationofthenameofthemanufacturer,packer,ordistributorshallbedeemedtobesatisfied,inthecaseofacorporation,onlybytheactualcorporatenamewhichmaybeprecededorfollowedbythenameoftheparticulardivisionofthecorporation.Abbreviationsfor"Company,""Incorp
3、orated,"etc.,maybeusedand"The"maybeomitted.Inthecaseofanindividual,partnership,orassociation,thenameunderwhichthebusinessisconductedshallbeused.对于制造商、包装商或分销商的名称，要提供公司的真实名称，在公司名称的前后可列出该公司特定部门的名称。公司名称可以使用"Company","Incorporated"等的缩写，其中的"The"可以省略。对于个体企业、合伙企业、或社团法人来说，
4、应当给出开展经营活动时使用的名称。(c)(c)Whereadeviceisnotmanufacturedbythepersonwhosenameappearsonthelabel,thenameshallbequalifiedbyaphrasethatrevealstheconnectionsuchpersonhaswithsuchdevice;suchas,"Manufacturedfor___","Distributedby_____",oranyotherwordingthatexpressesthefacts.如果
5、包装标识的单位名称不是制造单位，则应当对此名称加以限制，以表明与此标识上的单位与该产品的关系，可使用"Manufacturedfor___",或"Distributedby_____"说明。(d)(d)Thestatementoftheplaceofbusinessshallincludethestreetaddress,city,State,andZipCode;however,thestreetaddressmaybeomittedifitisshowninacurrentcitydirectoryortelephon
6、edirectory.TherequirementforinclusionoftheZIPCodeshallapplyonlytoconsumercommoditylabelsdevelopedorrevisedaftertheeffectivedateofthissection.Inthecaseofnonconsumerpackages,theZIPCodeshallappearoneitherthelabelorthelabeling(includingtheinvoice).经营地址的陈述应该包括州、市、街道和邮编
7、，（如果该地址在当前的城市或电话名录里可以查到，则可以省略）。对于在本节内容生效之后开发或修改的消费品，标签上要印有邮编，对于非消费品的包装来说，邮编可以印在外包装上，也可以印在其他地方，如发票上。(e)(e)Ifapersonmanufactures,packs,ordistributesadeviceataplaceotherthanhisprincipalplaceofbusiness,thelabelmaystatetheprincipalplaceofbusinessinlieuoftheactualplacew
8、heresuchdevicewasmanufacturedorpackedoristobedistributed,unlesssuchstatementwouldbemisleading如果某人不在经营地址生产、包装或分销器械，为了不引起误解，外包装上要陈述主要的经营地址，而不是实际生产、包装及分销地址
