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onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="j85mi3p" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/UploadFile/xunshi/637345817060751953/5365870.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="hdhyj5j" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價(jià)格要求：</span>面議</p><p><span>所在地：</span>上海市</p><p><span>包裝要求：</span><span style="color: #f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>河北追溯系統(tǒng)價(jià)格,UDI</p><p><span>***更新：</span>2021-02-01 07:12:12</p><p><span id="click" >瀏覽次數(shù)：0次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="fl3kzls" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">上海貞碼信息科技有限公司</a></p><p><span>聯(lián)系人：</span>貞碼科技陳先生</p><p><span>郵箱: </span>77740203@qq.com</p><p><span>電話: </span>18601787597</p><p><span>傳真: </span>18601_</p><p><span>網(wǎng)址: </span>http://www.idcodema.com</p><p><span>手機(jī): </span>18601-787597</p><p><span>地址: </span>上海市閔行區(qū)蓮花南路2899號(hào)蓮谷科技園1號(hào)樓A305室</p><p>[當(dāng)前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="jtn0zh8" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="hnhi0ga" class="box"><p><p style="text-indent:25px">醫(yī)療器械UDI注冊(cè)申報(bào)服務(wù)：法規(guī)依據(jù)。根據(jù)《UDI監(jiān)督管理?xiàng)l例》(有關(guān)部門令第650號(hào))的規(guī)定，對(duì)UDI按照風(fēng)險(xiǎn)程度實(shí)行分類管理。第Ⅰ類是風(fēng)險(xiǎn)程度低，實(shí)行常規(guī)管理可以保證其安全、有效的UDI，境內(nèi)生產(chǎn)企業(yè)需要在所在地市藥監(jiān)局進(jìn)行備案，境外UDI生產(chǎn)企業(yè)需要委托境內(nèi)代理人在CFDA進(jìn)行備案，河北追溯系統(tǒng)價(jià)格。第Ⅱ類是具有中度風(fēng)險(xiǎn)，需要嚴(yán)格控制管理以保證其安全、有效的UDI，境內(nèi)生產(chǎn)企業(yè)需要在所在地省(直轄市)藥監(jiān)局進(jìn)行注冊(cè)，河北追溯系統(tǒng)價(jià)格，境外UDI生產(chǎn)企業(yè)需要委托境內(nèi)代理人在CFDA進(jìn)行注冊(cè)。第Ⅲ類是具有較高風(fēng)險(xiǎn)，需要采取特別措施嚴(yán)格控制管理以保證其安全、有效的UDI，河北追溯系統(tǒng)價(jià)格，無(wú)論境內(nèi)、境外UDI生產(chǎn)企業(yè)均需要在CFDA進(jìn)行注冊(cè)。設(shè)備標(biāo)簽商必須在標(biāo)簽和包裝上以兩種形式提供UDI標(biāo)識(shí)。河北追溯系統(tǒng)價(jià)格</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北追溯系統(tǒng)價(jià)格,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345817060751953/5365870.png"></div><p style="text-indent:25px">如何選擇醫(yī)療器械UDI標(biāo)識(shí)數(shù)據(jù)載體呢？選擇醫(yī)療器械UDI標(biāo)識(shí)數(shù)據(jù)載體的方法有：射頻標(biāo)簽具有信息存儲(chǔ)功能，能接收讀寫(xiě)器的電磁調(diào)制信號(hào)，并返回相應(yīng)信號(hào)的數(shù)據(jù)載體。射頻標(biāo)簽的載體成本和識(shí)讀設(shè)備成本相較于一維碼和二維碼要高，但讀取速度快，可以實(shí)現(xiàn)批量讀取，在某些環(huán)節(jié)和領(lǐng)域能夠發(fā)揮作用。注冊(cè)人/備案人可根據(jù)產(chǎn)品的特征、價(jià)值、主要應(yīng)用場(chǎng)景等因素選擇適當(dāng)?shù)腢DI標(biāo)識(shí)數(shù)據(jù)載體。注冊(cè)人/備案人作為第1責(zé)任人負(fù)責(zé)落實(shí)，積極應(yīng)用標(biāo)識(shí)提升產(chǎn)品質(zhì)量和企業(yè)管理水平。青海商品質(zhì)量追溯根據(jù)UDI法規(guī)， UDI將會(huì)較大減少對(duì)美國(guó)市場(chǎng)中的醫(yī)療器械進(jìn)行充分識(shí)別的障礙。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北追溯系統(tǒng)價(jià)格,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345817165058594/5623915.png"></div><p style="text-indent:25px">UDI系統(tǒng)的出臺(tái)，另一方面也促進(jìn)了生產(chǎn)企業(yè)的轉(zhuǎn)型，對(duì)于產(chǎn)品召回和安全隱患帶來(lái)的利益損失，督促企業(yè)完善質(zhì)量管理體系，保證產(chǎn)品的有效和安全。UDI醫(yī)療器械特有標(biāo)識(shí)，是一種在醫(yī)療器械產(chǎn)品或者包裝上附載的，由數(shù)字、字母或者符號(hào)組成的代碼，用以對(duì)醫(yī)療器械進(jìn)行特有性識(shí)別。完整的UDI系統(tǒng)包括特有標(biāo)識(shí)、數(shù)據(jù)載體和數(shù)據(jù)庫(kù)三部分。特有標(biāo)識(shí)是醫(yī)療器械產(chǎn)品的電子身份證；數(shù)據(jù)載體是存儲(chǔ)或者傳輸醫(yī)療器械特有標(biāo)識(shí)的數(shù)據(jù)媒介；數(shù)據(jù)庫(kù)是儲(chǔ)存醫(yī)療器械特有標(biāo)識(shí)的產(chǎn)品標(biāo)識(shí)與關(guān)聯(lián)信息的數(shù)據(jù)庫(kù)。</p><p style="text-indent:25px">醫(yī)療器械UDI經(jīng)營(yíng)質(zhì)量管理規(guī)范：一、企業(yè)法定代表人、負(fù)責(zé)人、質(zhì)量管理人員應(yīng)當(dāng)熟悉UDI監(jiān)督管理的法律法規(guī)、規(guī)章規(guī)范和所經(jīng)營(yíng)UDI的相關(guān)知識(shí)，并符合有關(guān)法律法規(guī)及本規(guī)范規(guī)定的資格要求?？刹扇‖F(xiàn)場(chǎng)詢問(wèn)、問(wèn)卷調(diào)查、閉卷考試等方式了解企業(yè)法定代表人、負(fù)責(zé)人、質(zhì)量管理人員是否熟悉UDI監(jiān)督管理的法律法規(guī)、規(guī)章規(guī)范和所經(jīng)營(yíng)UDI的相關(guān)知識(shí)，是否符合有關(guān)法律法規(guī)及UDI經(jīng)營(yíng)質(zhì)量管理規(guī)范規(guī)定的資格要求。二、企業(yè)質(zhì)量負(fù)責(zé)人負(fù)責(zé)UDI質(zhì)量管理工作，應(yīng)當(dāng)**履行職責(zé)，在企業(yè)內(nèi)部對(duì)UDI質(zhì)量管理具有裁決權(quán)，承擔(dān)相應(yīng)的質(zhì)量管理責(zé)任。UDI表示著一個(gè)國(guó)家高新技術(shù)的綜合實(shí)力。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="河北追溯系統(tǒng)價(jià)格,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345816960800781/3253542.png"></div><p style="text-indent:25px">醫(yī)療器械UDI國(guó)際化合規(guī)性：第1條、為規(guī)范UDI標(biāo)識(shí)系統(tǒng)建設(shè)，加強(qiáng)UDI全生命周期管理，根據(jù)《UDI監(jiān)督管理?xiàng)l例》，制定本規(guī)則。第二條、在我國(guó)境內(nèi)銷售、使用的UDI，其標(biāo)識(shí)系統(tǒng)應(yīng)當(dāng)符合本規(guī)則。第三條、本規(guī)則所稱UDI標(biāo)識(shí)系統(tǒng)，由UDI標(biāo)識(shí)、標(biāo)識(shí)數(shù)據(jù)載體和標(biāo)識(shí)數(shù)據(jù)庫(kù)組成。UDI標(biāo)識(shí)，是指在UDI產(chǎn)品或者包裝上附載的，由數(shù)字、字母或者符號(hào)組成的代碼，用于對(duì)UDI進(jìn)行性識(shí)別。UDI標(biāo)識(shí)數(shù)據(jù)載體，是指存儲(chǔ)或者傳輸U(kuò)DI標(biāo)識(shí)的數(shù)據(jù)媒介。UDI標(biāo)識(shí)數(shù)據(jù)庫(kù)，是指儲(chǔ)存UDI標(biāo)識(shí)的產(chǎn)品標(biāo)識(shí)與關(guān)聯(lián)信息的數(shù)據(jù)庫(kù)。UDI標(biāo)識(shí)的發(fā)碼機(jī)構(gòu)應(yīng)當(dāng)為中國(guó)境內(nèi)的法人機(jī)構(gòu)。河北追溯系統(tǒng)價(jià)格</p><p style="text-indent:25px">目前市面上常用的UDI數(shù)據(jù)載體包括一維碼、二維碼和RFID射頻識(shí)別標(biāo)簽等。河北追溯系統(tǒng)價(jià)格</p><p style="text-indent:25px">制定《UDI操作規(guī)程》。UDI需要滿足自動(dòng)識(shí)別與數(shù)據(jù)采集以及人工識(shí)讀要求。公司確定DI（產(chǎn)品標(biāo)識(shí)，指產(chǎn)品的詳細(xì)型號(hào)、版本、配置）采用GTIN-14來(lái)實(shí)現(xiàn)不同包裝級(jí)別的條碼標(biāo)識(shí)。同時(shí)確定PI（生產(chǎn)標(biāo)識(shí)，可包括產(chǎn)品批號(hào)、序列號(hào)、效期、生產(chǎn)日期等）至少應(yīng)包含生產(chǎn)日期、生產(chǎn)批號(hào)和失效日期。此外，PI部分根據(jù)產(chǎn)品不同可適當(dāng)增加其他信息。選擇UDI載體。UDI載體包括一維碼、二維碼和射頻標(biāo)簽等，我們選擇一維和/或二維碼作為產(chǎn)品的UDI載體。其中一維碼采用GS1-128條碼，根據(jù)空間大小，可以采用串聯(lián)或并聯(lián)形式來(lái)實(shí)現(xiàn)。二維碼主要包括Data Matrix、QR和漢信碼三種形式，威高選用的是Date Matrix條碼。通過(guò)對(duì)不同UDI載體的綜合對(duì)比分析，二維碼具有明顯優(yōu)勢(shì)。河北追溯系統(tǒng)價(jià)格</p><p style="text-indent:25px">上海貞碼信息科技有限公司為企業(yè)提供用于對(duì)任何類型的對(duì)象（人、事、物）進(jìn)行全球二維碼身份標(biāo)識(shí)，即“二維碼身份證”。上海貞碼信息科技有限公司與上海統(tǒng)一二維碼標(biāo)識(shí)注冊(cè)管理中心合作開(kāi)通了 IDcode 碼的發(fā)碼，現(xiàn)在具備發(fā)行符合 ISO/IEC15459 標(biāo)準(zhǔn)的國(guó)際標(biāo)準(zhǔn)的二維碼，是統(tǒng)一二維碼標(biāo)識(shí)注冊(cè)管理中心的 SP 服務(wù)商。上海貞碼信息科技有限公司以“以創(chuàng)造為動(dòng)力，以品質(zhì)為基礎(chǔ)”為重要價(jià)值，希望通過(guò)我們的專業(yè)水平和不懈努力，重塑中小企業(yè)網(wǎng)絡(luò)形象，為企業(yè)產(chǎn)品推廣、文化建設(shè)傳播提供服務(wù)指導(dǎo)。</p></p><br /><p>文章來(lái)源地址: http://m.cdcfah.com/cp/3108499.html</p></div></div></div></div></div><div id="je0getc" class="page-right twoColRt"><div id="086y0ef" class="box01 margin10 clearfix"><h3><a href="http://m.cdcfah.com/cp/">猜你喜歡</a></h3><div id="q0fcn0v" class="recomPic likePro"><a href="http://m.cdcfah.com/cp/814588.html"><div><img src="http://tyunfile.71360.com/UpLoadFile/2019/11/1/14/637082168864691056_lgpj_5374157.jpg" alt="福建ZF配件哪家強(qiáng) 信息推薦自業(yè)物資供應(yīng)" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></div><p>福建ZF配件哪家強(qiáng) 信息推薦自業(yè)物資供應(yīng)</p></a></div><div id="ll0jr35" class="recomPic likePro"><a href="http://m.cdcfah.com/cp/846569.html"><div><img src="https://tyunfile.71360.com/WaterMark/UploadFile/nbzxsw/637298235378037109/764794.png" 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