臺灣核心實作指引(TW Core IG)
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This page is part of the 臺灣核心實作指引(TW Core IG) (v0.1.0: Releases) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

: 臺灣醫療器材許可證 - XML Representation

Active as of 2022-08-08

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="medication-device-fda-tw"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p>This code system <code>https://twcore.mohw.gov.tw/ig/twcore/CodeSystem/medication-device-fda-tw</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032535號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032535.34399"> </a></td><td>&quot;靈威特&quot;麥克費爾電池式動力系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032536號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032536.34399"> </a></td><td>&quot;美萊格&quot;蒸氣滅菌器</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032537號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032537.34399"> </a></td><td>&quot;雷柏瑞&quot;膀胱注射針</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032538號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032538.34399"> </a></td><td>&quot;史得勞曼&quot;牙科植體系統(骨高度全錐型)-癒合用配件</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032539號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032539.34399"> </a></td><td>&quot;史賽克&quot;排煙筆及其電極</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032540號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032540.34399"> </a></td><td>&quot;奧林柏斯&quot;電燒灼裝置</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032541號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032541.34399"> </a></td><td>&quot;奧林柏斯&quot;高頻切除電極</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032542號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032542.34399"> </a></td><td>3M舒適繃含藥型</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032543號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032543.34399"> </a></td><td>&quot;史得勞曼&quot;多功能支台齒</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032544號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032544.34399"> </a></td><td>&quot;柏朗&quot;雅氏後路椎間盤融合系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032545號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032545.34399"> </a></td><td>&quot;悅廷和&quot;蒸氣滅菌器</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032546號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032546.34399"> </a></td><td>&quot;史泰瑞&quot;消化道止血夾系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032547號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032547.34399"> </a></td><td>&quot;泰妍醫療&quot;貝雷思球囊椎體成形術套組</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032548號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032548.34399"> </a></td><td>&quot;柯惠&quot;索尼西迅彎鉗無線超音波刀系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032549號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032549.34399"> </a></td><td>&quot;滴愛畢&quot;間歇自我導尿管</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032550號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032550.34399"> </a></td><td>&quot;伸特耐-脊椎&quot;司特立頸椎椎間融合器</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032551號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032551.34399"> </a></td><td>&quot;恩伊&quot;簡單植軟體系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032552號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032552.34399"> </a></td><td>&quot;飛利浦&quot;醫療影像傳輸、處理暨儲存系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032553號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032553.34399"> </a></td><td>&quot;日本光電&quot;床邊生理監視器</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032554號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032554.34399"> </a></td><td>&quot;美瑞特&quot;赫思瓣可控式導引鞘管</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032555號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032555.34399"> </a></td><td>&quot;銳能&quot;預裝式疏水性非球面人工水晶體推注系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032556號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032556.34399"> </a></td><td>&quot;博醫來&quot;電腦治療計畫系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032557號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032557.34399"> </a></td><td>&quot;卡比&quot;艾捷莉幫浦整合系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032558號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032558.34399"> </a></td><td>&quot;瑞思邁&quot;艾克舒氣道正壓呼吸器</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032559號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032559.34399"> </a></td><td>&quot;思倍秀&quot;影像引導導管</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032560號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032560.34399"> </a></td><td>&quot;全頌尼科&quot;愛雅莎體外維生系統監視儀</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032561號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032561.34399"> </a></td><td>&quot;西門子&quot;磁振造影儀</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032562號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032562.34399"> </a></td><td>&quot;蔡司&quot;眼部光學斷層掃描儀</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032563號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032563.34399"> </a></td><td>&quot;磊仕&quot;陽壓呼吸系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032564號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032564.34399"> </a></td><td>&quot;席科特&quot;手術計畫軟體</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032565號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032565.34399"> </a></td><td>海豚牙科影像規劃軟體</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032566號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032566.34399"> </a></td><td>&quot;恩提愛&quot;瑞艾特導管</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032567號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032567.34399"> </a></td><td>&quot;西門子&quot;單光子電腦斷層/電腦斷層掃描儀</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032568號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032568.34399"> </a></td><td>&quot;西門子&quot;超音波系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032569號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032569.34399"> </a></td><td>BD福徠喜預充式導管沖洗器</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032570號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032570.34399"> </a></td><td>&quot;蔡司&quot;全飛秒雷射角膜儀</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032571號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032571.34399"> </a></td><td>&quot;飛利浦&quot;磁振造影系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032572號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032572.34399"> </a></td><td>&quot;柯惠&quot;雪莉經口/鼻無氣囊氣管內管</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032573號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032573.34399"> </a></td><td>福樂顯連續式輸液套組</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032574號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032574.34399"> </a></td><td>&quot;護比自&quot;非接觸式眼壓計/角膜厚度測量儀</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032575號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032575.34399"> </a></td><td>&quot;諾寧&quot;多功能血氧測量系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032576號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032576.34399"> </a></td><td>&quot;摩托拉&quot;心電圖機</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032577號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032577.34399"> </a></td><td>&quot;飛利浦&quot;臨床資訊系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032578號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032578.34399"> </a></td><td>&quot;西門子&quot;磁振造影儀</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032579號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032579.34399"> </a></td><td>三曼西歐影像工作站</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032580號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032580.34399"> </a></td><td>希艾斯影像工作站</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032581號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032581.34399"> </a></td><td>&quot;柯惠&quot;奈普特呼吸器</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032582號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032582.34399"> </a></td><td>&quot;朝日&quot;塞時給雙腔導管</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032583號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032583.34399"> </a></td><td>&quot;錫樂&quot;心電圖系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032584號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032584.34399"> </a></td><td>&quot;瑞思邁&quot;易適面罩</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032585號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032585.34399"> </a></td><td>&quot;比提翼&quot;醫療可測量用運動設備</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032586號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032586.34399"> </a></td><td>&quot;蔡司&quot;廣角眼底攝影機</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032587號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032587.34399"> </a></td><td>&quot;飛利浦&quot;電腦斷層造影系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032588號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032588.34399"> </a></td><td>&quot;波士頓科技&quot;安博倫電極傳送系統</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032589號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032589.34399"> </a></td><td>&quot;環科&quot;醫學影像處理軟體</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032590號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032590.34399"> </a></td><td>&quot;亞瑟&quot;立適紅外線雷射治療儀</td></tr><tr><td style="white-space:nowrap">衛部醫器輸字第032591號<a name="medication-device-fda-tw-.34907.37096.37291.22120.36664.23383.31532032591.34399"> </a></td><td>&quot;美敦力&quot;亞善達植入式脊髓腔內導管</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000766號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000766.34399"> </a></td><td>亞培新世代4000白血球試劑B</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000767號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000767.34399"> </a></td><td>&quot;康美-靈威特&quot;鋼針打入器(未滅菌)</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000768號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000768.34399"> </a></td><td>傑仕第根管長度測量儀</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000769號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000769.34399"> </a></td><td>康威護膜抹巾(未滅菌)</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000770號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000770.34399"> </a></td><td>&quot;必帝&quot;生物環境培養系統(未滅菌)</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000771號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000771.34399"> </a></td><td>優湃彎曲桿菌鑑定套組(滅菌)</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000772號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000772.34399"> </a></td><td>優湃革蘭氏陰性菌鑑定套組(滅菌)</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000773號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000773.34399"> </a></td><td>優湃厭氧菌鑑定套組(滅菌)</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000774號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000774.34399"> </a></td><td>亞培乳酸脫氫酶試劑</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000775號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000775.34399"> </a></td><td>&quot;理聲&quot;貝爾通助聽器(未滅菌)</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000776號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000776.34399"> </a></td><td>亞培TDx溶液系統組</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000777號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000777.34399"> </a></td><td>3M牙科矯正頰側管(未滅菌)</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000778號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000778.34399"> </a></td><td>韓福瑞視野計</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000779號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000779.34399"> </a></td><td>&quot;西門子&quot;N抗人類血清之載體脂蛋白B檢驗試劑(未滅菌)</td></tr><tr><td style="white-space:nowrap">衛署醫器輸壹字第000780號<a name="medication-device-fda-tw-.34907.32626.37291.22120.36664.22777.23383.31532000780.34399"> </a></td><td>日水GAM半固體培養基(未滅菌)</td></tr></table></div>
  </text>
  <url
       value="https://twcore.mohw.gov.tw/ig/twcore/CodeSystem/medication-device-fda-tw"/>
  <version value="2022-08-08"/>
  <name value="TWMedicationDeviceFDA"/>
  <title value="臺灣醫療器材許可證"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2022-08-08"/>
  <contact>
    <name value="衛生福利部"/>
    <telecom>
      <system value="url"/>
      <value value="https://www.mohw.gov.tw/"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="CCYU@mohw.gov.tw"/>
    </telecom>
  </contact>
  <description
               value="臺灣醫療器材許可證,參照自[https://data.fda.gov.tw/frontsite/data/DataAction.do?method=doDetail&amp;infoId=68](https://data.fda.gov.tw/frontsite/data/DataAction.do?method=doDetail&amp;infoId=68)  
代碼出版日期:2022-08-08;資料所屬單位:衛生福利部食品藥物管理署。

*因原始資料無代碼版本資訊,故使用其「更新日期」作為版本資訊。*  

因代碼量較大會使載入頁面時間較長,為方便使用者瀏覽,此處僅擷取部分代碼,完整代碼可至全國專門術語服務平台([https://twcore.mohw.gov.tw/tsfhir/CodeSystem/medication-device-fda-tw](https://twcore.mohw.gov.tw/ts/codesystemRead.jsp?id=medication-device-fda-tw&amp;status=active&amp;version=2022-08-08&amp;metaId=1&amp;codeStatus=use&amp;show=Y){:target=&quot;_blank&quot;})查閱"/>
  <copyright value="衛生福利部食品藥物管理署"/>
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  <content value="complete"/>
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  <concept>
    <code value="衛部醫器輸字第032535號"/>
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    <code value="衛部醫器輸字第032536號"/>
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    <code value="衛部醫器輸字第032574號"/>
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</CodeSystem>