13485問卷調(diào)查表-資料下載頁
2025-07-24 01:32本頁面
【正文】 Please use additional sheet if necessary 必要時(shí)分頁使用 Products 產(chǎn)品Do you sell some products with your own name on the label?是否銷售帶有自己名字標(biāo)簽的產(chǎn)品YesNoDo you use or incorporate into devices animal material or derivatives (gelatine, collagen)? 醫(yī)療器械里是否使用動物材料及動物材料衍生物（例如：膠質(zhì)，膠原質(zhì)）？YesNoIf YES, please give details如有，請給出詳情Do you use or incorporate into devices medicinal products or pharmaceuticals?醫(yī)療器械中是否聯(lián)合藥品或醫(yī)藥品一起使用？YesNoIf YES, please give details如有，請給出詳情Do you sell other panies devices under your own name (own branding)?是否用自己的名字（或品牌）銷售其他公司的產(chǎn)品？YesNoIf YES, please give brief product ranges, names of OEMs and send copies of 93/42/EEC certification如果是，請給出產(chǎn)品的主要范圍、OEM產(chǎn)品的名稱和93/42/EEC認(rèn)證的復(fù)印件CMDCAS certification only 只對CMDCAS認(rèn)證Define range of products for which you have current Canadian Licence or attach list在下表中描述已獲取加拿許可證的產(chǎn)品的范圍Product產(chǎn)品Licence Number許可證號Class等級Product產(chǎn)品Licence Number許可證號Class等級Define range of products for which you propose to seek a Canadian Licence在下表中描述希望獲取加拿許可證的產(chǎn)品的范圍Product產(chǎn)品Class等級Product產(chǎn)品Class等級Product產(chǎn)品Class等級FDA audits only 只針對FDA的審核Define range of products sold or to be sold in USA, 詳述賣到美國或被美國賣的產(chǎn)品的范圍Taiwan only 只針對臺灣Define range of products sold or to be sold in Taiwan 詳述賣到臺灣或被臺灣賣的產(chǎn)品的范圍Japan only 只針對日本Define range of products sold or to be sold in Japan 詳述賣到日本或被日本賣的產(chǎn)品的范圍Product Types to be included under Directive 93/42/EEC 包含在93/42/EEC指令中的產(chǎn)品類型 (CE認(rèn)證)Product Type產(chǎn)品類型Approximate Number of Product Families Manufactured制造該類產(chǎn)品的大約數(shù)量Annex IX Class 1,IIa,IIb,3(1), 附錄Ⅸ分類1,IIa,IIb,3(1)Product Standards(2) 產(chǎn)品標(biāo)準(zhǔn)第 7 頁 共 7
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