您需要歐代

為什么您需要歐盟授權代表?

       按照歐盟官方指令,凡設立在歐盟以外的,生產醫療器械、體外診斷醫療器械、個人防護用品、化妝品、機械類、玩具類的制造商必須為自身指定一個歐盟授權代表(EC Representative,簡稱歐代)。 歐代的職責在歐盟指令中均有具體規定。

       總之,凡是涉及健康、安全、環保的建筑產品都將加貼CE標志才可進入歐盟市場,這些生產廠家和貿易商都必須指定一個歐盟授權代表。

具體見下表:

指令名稱 (英文/中文)主要指令編號
Medical Devices醫療器械指令93/42/EEC
In Vitro Diagnostic Medical Devices體外診斷器械指令98-79-EC
Active Implantable Medical Devices 有源醫療器械指令90/385/EEC
Simple Pressure-vessels 簡單壓力容器指令87/404/EEC
Toys 玩具指令2009/48/EC
Construction Products 建筑產品89/106/EEC
Electromagnetic Compatibility 電磁相容指令89/336/EEC
Machines機械指令2006/42/EC
Personal Protective Equipment 個人防護設備指令90/686/EEC
Non-automatic Weighing Machines 非自動稱量儀器指令90/384/EEC
Gas Appliances 燃氣器具指令90/396/EEC
Telecommunications Terminal Equipement 電信終端設備指令91/263/EEC
Boilers 鍋爐指令92/42/EEC
Civic Explosives爆破器材指令93/15/EEC
Low Voltage Electrical Products 低電壓指令73/23/EEC
Satellite Earth Station for Telecommunications 通訊衛星地面站指令93/97/EEC
Lifts升降設備95/16/EC
Equipment for Use in Explosive Atmospheres 用于爆炸性氣體設備指令94/09/EC
Recreational Craft (Boats) 娛樂用船只指令94/25/EC
Equipment Pressure 壓力容器97/23/EC
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