青海一物一碼追溯 **** 上海貞碼信息科技供應(yīng)-b2b網(wǎng)站_b2b電子商務(wù)平臺(tái)【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="如何選擇醫(yī)療器械UDI標(biāo)識(shí)數(shù)據(jù)載體？上海貞碼信息科技有限公司小編介紹，當(dāng)前市面上常用的數(shù)據(jù)載體包括一維碼、二維碼和射頻標(biāo)簽，青海一物一碼追溯。一維碼是只在一維方向上表示信息的條碼符號(hào)，應(yīng)用多年已經(jīng)很成熟，成本低，能很好兼容市面上現(xiàn)有的掃碼設(shè)"><meta name="keywords" content="青海一物一碼追溯,UDI"><link rel="canonical" href="http://www.cdcfah.com/"/><meta name="applicable-device" content="pc"><link rel="shortcut icon" href="/static/new_net_01/images/favicon.ico"><link rel="stylesheet" href="/static/new_net_01/css/slick.css" /><link rel="stylesheet" href="/static/new_net_01/css/addnew.css"><link rel="stylesheet" href="/static/new_net_01/css/sidenav.css"><link rel="stylesheet" href="/static/new_net_01/css/style.css" /><link rel="stylesheet" href="/static/new_net_01/css/tab.css"><link rel="stylesheet" href="/static/new_net_01/css/404.css"> <meta name="baidu-site-verification" content="OBVzrC9aaQ" /> <meta 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href="http://www.cdcfah.com/cp/">產(chǎn)品供應(yīng)</a>?<a href="http://www.cdcfah.com/cp/second-_swfw/">商務(wù)服務(wù)</a>?<a href="http://www.cdcfah.com/cp/third-swfw_qtswfw/">其他商務(wù)服務(wù)</a>?青海一物一碼追溯 **** 上海貞碼信息科技供應(yīng)</p><div id="zsp9neq" class="leftbox clearfix"><h1>青海一物一碼追溯 **** 上海貞碼信息科技供應(yīng)</h1><div id="kjq9gxo" class="proBig"><div id="29yprd7" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/UploadFile/xunshi/637345817165058594/5623915.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="3zedev3" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/UploadFile/xunshi/637345817165058594/5623915.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="svcgxov" 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>青海一物一碼追溯,UDI</p><p><span>***更新：</span>2020-09-03 21:34:14</p><p><span id="click" >瀏覽次數(shù)：10次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="32tpb7p" 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="c7lip4t" class="page-proshow02"><p class="title">詳細(xì)說(shuō)明</p><div id="yhji8iu" class="box"><p><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？上海貞碼信息科技有限公司小編介紹，當(dāng)前市面上常用的數(shù)據(jù)載體包括一維碼、二維碼和射頻標(biāo)簽，青海一物一碼追溯。一維碼是只在一維方向上表示信息的條碼符號(hào)，應(yīng)用多年已經(jīng)很成熟，成本低，能很好兼容市面上現(xiàn)有的掃碼設(shè)備，但一唯碼所占空間大，破損糾錯(cuò)能力差。二維碼是在二維方向上都表示信息的條碼符號(hào)，相比于一維碼，相同空間能夠容納更多的數(shù)據(jù)，在器械包裝尺寸受限的時(shí)候能發(fā)揮很好的作用，具備一定的糾錯(cuò)能力，青海一物一碼追溯，但對(duì)識(shí)讀設(shè)備的要求相較于一維碼要高，青海一物一碼追溯。醫(yī)療技術(shù)、藥品、醫(yī)療器械UDI是構(gòu)成醫(yī)療服務(wù)體系的三大支柱。青海一物一碼追溯</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="青海一物一碼追溯,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345817165058594/5623915.png"></div><p style="text-indent:25px">醫(yī)療器械UDI經(jīng)營(yíng)質(zhì)量管理規(guī)范，現(xiàn)場(chǎng)檢查指導(dǎo)原則：企業(yè)法定負(fù)責(zé)人或者負(fù)責(zé)人是醫(yī)療器械UDI經(jīng)營(yíng)質(zhì)量的主要責(zé)任人，詳細(xì)負(fù)責(zé)企業(yè)日常管理。重點(diǎn)查看企業(yè)相關(guān)制度文件或職責(zé)權(quán)限文件，確認(rèn)文件內(nèi)容是否明確企業(yè)法定負(fù)責(zé)人或者負(fù)責(zé)人是醫(yī)療器械UDI經(jīng)營(yíng)質(zhì)量的主要負(fù)責(zé)人；查看法定負(fù)責(zé)人或者負(fù)責(zé)人履行職責(zé)的相關(guān)記錄（如法定負(fù)責(zé)人或者負(fù)責(zé)人授權(quán)文件、任命文件簽發(fā)，資源配置批準(zhǔn)，重大事項(xiàng)決定等），確認(rèn)其是否詳細(xì)負(fù)責(zé)企業(yè)日常管理工作。江蘇質(zhì)量追溯體系醫(yī)療器械UDI是國(guó)際公認(rèn)的高新技術(shù)產(chǎn)業(yè)，具有高技術(shù)密集、學(xué)科交叉普遍、技術(shù)集成融合等特點(diǎn)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="青海一物一碼追溯,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345817380947266/8402115.png"></div><p style="text-indent:25px">醫(yī)療器械UDI注冊(cè)類型：體外診斷試劑。1.備案：無(wú)論境外如何管理，境內(nèi)按第Ⅰ類醫(yī)療器械UDI管理的產(chǎn)品2.初次注冊(cè)：（1）第Ⅱ、Ⅲ類體外診斷試劑產(chǎn)品初次進(jìn)入中國(guó)市場(chǎng)；（2）已上市銷售產(chǎn)品基本反應(yīng)原理改變；（3）已上市銷售產(chǎn)品分析靈敏度指標(biāo)改變，并具有新的臨床診斷意義；其他影響產(chǎn)品性能的重大改變。3.延續(xù)注冊(cè)：在醫(yī)療器械UDI注冊(cè)證書有效期屆滿后仍需繼續(xù)生產(chǎn)、銷售的產(chǎn)品應(yīng)在注冊(cè)證書有效期屆滿6個(gè)月前、且有效期屆滿前12個(gè)月內(nèi)提出申請(qǐng)。</p><p style="text-indent:25px">醫(yī)療器械UDI經(jīng)營(yíng)質(zhì)量管理規(guī)范：第三類醫(yī)療器械UDI經(jīng)營(yíng)企業(yè)質(zhì)量負(fù)責(zé)人應(yīng)當(dāng)具備醫(yī)療器械UDI相關(guān)專業(yè)（相關(guān)專業(yè)指醫(yī)療器械UDI、生物醫(yī)學(xué)工程、機(jī)械、電子、醫(yī)學(xué)、生物工程、化學(xué)、藥學(xué)、護(hù)理學(xué)、康復(fù)、檢驗(yàn)學(xué)、計(jì)算機(jī)、法律、管理等）大專以上學(xué)歷或者中級(jí)以上專業(yè)技術(shù)職稱，同時(shí)應(yīng)當(dāng)具有3年以上醫(yī)療器械UDI經(jīng)營(yíng)質(zhì)量管理工作經(jīng)歷。重點(diǎn)查看企業(yè)員工名冊(cè)、質(zhì)量管理人員勞動(dòng)用工合同、簡(jiǎn)歷、離職證明、學(xué)歷或職稱等證明文件，確認(rèn)企業(yè)質(zhì)量管理人員相關(guān)專業(yè)學(xué)歷或者職稱等資質(zhì)是否符合上述要求。醫(yī)療器械UDI產(chǎn)品標(biāo)識(shí)是識(shí)別注冊(cè)人/備案人、醫(yī)療器械型號(hào)規(guī)格和包裝的代碼。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="青海一物一碼追溯,UDI" src="https://tyunfile.71360.com/UploadFile/xunshi/637345817450019531/4187422.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?射頻標(biāo)簽具有信息存儲(chǔ)功能，能接收讀寫器的電磁調(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)尼t(yī)療器械UDI標(biāo)識(shí)數(shù)據(jù)載體。注冊(cè)人/備案人作為第一責(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。醫(yī)療器械UDI滿足醫(yī)療器械流通和使用環(huán)節(jié)精細(xì)化識(shí)別和記錄的需求。青海UDI</p><p style="text-indent:25px">從有關(guān)部門管理角度看，對(duì)于醫(yī)療器械UDI監(jiān)管，利用標(biāo)識(shí)，可構(gòu)建醫(yī)療器械監(jiān)管大數(shù)據(jù)。青海一物一碼追溯</p><p style="text-indent:25px">標(biāo)識(shí)具備性、穩(wěn)定性和可擴(kuò)展性的原則。性是首要原則，是確保產(chǎn)品精確識(shí)別的基礎(chǔ)，是標(biāo)識(shí)發(fā)揮功能的重要原則。由于醫(yī)療器械UDI產(chǎn)品的復(fù)雜性，性應(yīng)當(dāng)與產(chǎn)品識(shí)別要求相一致，對(duì)于相同特征的醫(yī)療器械UDI，性應(yīng)當(dāng)指向單個(gè)規(guī)格型號(hào)產(chǎn)品；對(duì)于按照批次生產(chǎn)控制的產(chǎn)品，性指向同批次產(chǎn)品；而對(duì)于采用序列號(hào)生產(chǎn)控制的醫(yī)療器械UDI，性應(yīng)當(dāng)指向單個(gè)產(chǎn)品。對(duì)于醫(yī)保部門，有助于在采購(gòu)招標(biāo)中精確識(shí)別醫(yī)療器械UDI，推動(dòng)實(shí)現(xiàn)結(jié)算透明化，打擊**和濫用行為。青海一物一碼追溯</p><p style="text-indent:25px">上海貞碼信息科技有限公司致力于通信產(chǎn)品，是一家服務(wù)型公司。公司業(yè)務(wù)分為生碼打碼客戶端，碼標(biāo)，智能追溯，掃碼通VA等，目前不斷進(jìn)行創(chuàng)新和服務(wù)改進(jìn)，為客戶提供良好的產(chǎn)品和服務(wù)。公司將不斷增強(qiáng)企業(yè)重點(diǎn)競(jìng)爭(zhēng)力，努力學(xué)習(xí)行業(yè)知識(shí)，遵守行業(yè)規(guī)范，植根于通信產(chǎn)品行業(yè)的發(fā)展。貞碼科技憑借創(chuàng)新的產(chǎn)品、專業(yè)的服務(wù)、眾多的成功案例積累起來(lái)的聲譽(yù)和口碑，讓企業(yè)發(fā)展再上新高。</p></p><br /><p>文章來(lái)源地址: http://www.cdcfah.com/cp/1146515.html</p></div></div></div></div></div><div id="wv7pox7" 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