台灣醫療器材
許可證資料查詢
MEDCHECK許可證索引
衛署醫器輸字
許可證編號021554
輸入器材
醫療器材許可證 ／ 輸入器材

“羅丹”Delta全血血栓彈性分析系統

Rotem "Delta" whole blood thromboelastometry system

衛署醫器輸字第021554號
本站收錄狀態核准有效
有效日期2030 / 09 / 30
醫療器材級數第二等級

申請商為 常鈺醫療器材有限公司，收錄 15 個 UDI 型號。 以下整理許可證、規格與製造廠資料，供核對產品身分使用。

許可證資料 依公開資料欄位整理

許可證字號
衛署醫器輸字第021554號
申請商
常鈺醫療器材有限公司 （查看此申請商全部許可證）
統一編號
89637068
申請商地址
新北市中和區建八路165號2樓
發證日期
2010 / 09 / 30
有效日期
2030 / 09 / 30
限制項目
輸 入
資料異動日期
2026 / 01 / 23

這類器材是什麼 體外凝集研究之多功能系統，AI 輔助整理

這類器材是醫院檢驗室用來檢查血液凝固功能的儀器、試劑和品管液，不是民眾在家自己用的東西。抽血後由醫檢師操作，用來評估凝血快慢、監測抗凝血藥物或找出血原因。

它到底驗什麼

核心是把血液或血漿加進試劑，觀察凝血的快慢。常見的項目包括凝血酶原時間（PT）、活化部分凝血活酶時間（aPTT）、D-二聚體、凝血因子和抗體等。

  • 凝血功能篩檢：手術前、出血或血栓評估時常做。
  • 藥物監測：使用肝素、口服抗凝血藥時，追蹤藥效。
  • 找原因：懷疑凝血因子缺乏、抗體干擾或血栓時，進一步檢驗。

為什麼要搭配品管液和校正液

檢驗結果要能互相比較，儀器和試劑必須先校正，每天再用已知濃度的品管液確認表現。品名裡的「校正液」「校正血漿」「品管液」就是這個用途。這類品項和檢驗試劑是成套的，換批號或換儀器時都可能需要重新校正。

誰會用到它

  • 醫院或檢驗所的醫檢師，是實際操作的人。
  • 需要評估凝血功能的病人，由醫師開立檢驗。
  • 接受抗凝血藥物治療的人，用來追蹤藥效。
  • 手術前後的病人，作為出血風險評估的一部分。

在台灣買得到嗎

這類產品全部是進口，本站收錄的 49 張有效許可證，製造廠以美國、德國、法國為主。它屬於第 2 等級醫療器材，須由醫療院所或合格檢驗單位採購，一般民眾不會在藥局或網購看到。包裝上的許可證字號格式像「衛部醫器輸字第○○○○○○號」，可在本站查驗。

常見問題

這類器材可以自己在家驗凝血嗎？

不行。這類系統是給檢驗室用的儀器和試劑，需要專業操作、校正和品管，不是設計給民眾在家自我檢測。想了解自己的凝血狀況，要由醫師開立檢驗、在醫療院所抽血。

驗凝血功能需要空腹嗎？

通常不需要。凝血相關檢驗多半不受進食影響，但如果你同時要驗血糖、血脂等項目，就可能需要空腹。實際要求依檢驗單和醫療院所的說明為準。

吃抗凝血藥會影響檢驗結果嗎？

會。抗凝血藥物的作用就是改變凝血速度，所以檢驗數值本來就會受影響，醫師也會用它來調整用藥。抽血前請照常服藥，除非醫師另有交代，不要自行停藥或改劑量。

檢驗結果異常就代表有血栓嗎？

不一定。凝血檢驗異常可能來自藥物、肝臟功能、感染、懷孕或檢體處理等因素，單一數值不能直接診斷血栓或出血疾病。要由醫師搭配症狀、病史和其他檢查一起判斷。

本段由 AI 依官方分類輔助整理，僅供認識器材之用，不構成醫療建議。使用前請以醫師指示與產品仿單為準。

UDI 標示 依 UDI 資料彙整

  • 單次使用是
  • 滅菌包裝否
  • 天然橡膠（乳膠）不含
  • DEHP不含
  • 批號有
  • 序號有
  • 製造日期有
  • 有效期限有
  • 健保特材未填

這張許可證底下有多個型號時，只要其中一款有標示，就顯示為「是」或「有」。

效能與規格

效能
此系統適用來監測血樣在凝血過程中定量及定性的變化。此系統記錄含有citrated 血樣在形成血塊乃至瓦解之動力學變化，其目的在將血塊形成中產生的不同參數經檢冊、分析、監測、判讀及圖形化。
規格
200100-EN, 20011, 503-01, 503-10, 503-02, 503-03, 503-04, 503-05, 503-06, 503-09, 503-24, 503-25, 503-12, 503-13, 503-15, 503-16, 503-19
(一)產品包裝（503-12:20×1,503-13:20×1,503-15:20×1,503-16:20×1,503-19:20×1）、效期（12個月）變更：詳如中文仿單核定本（原99年11月25日核發之中文仿單核定本收回作廢）。
(二)規格變更：註銷503-03。
200100-EN型號變更為：000201014。
標籤及仿單變更為：詳如中文仿單核定本（原104年8月27日仿單標籤核定本正本收回作廢）。
註銷規格：503-01、503-12、503-13、503-15、503-16、503-19，以下空白。
註銷型號000201014、型號503-05之名稱變更為ex-tem、型號503-10之名稱變更為star-tem及醫療器材規格與標籤、說明書或包裝變更為：詳如醫療器材標籤、說明書或包裝核定本(原109年12月22日醫療器材仿單標籤核定本回收作廢)。以下空白

製造廠

製造商
TEM INNOVATIONS GMBH
國別
德國
廠址
MARTIN-KOLLAR-STRABE 15 D-81829 MUNCHEN GERMANY
製造許可登錄編號
QSD12748

UDI 型號 共 15 筆

此許可證底下的 UDI 型號
基本 DI型號產品描述單次使用乳膠DEHP
04260160470204503-13-20The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF). 是 否 否
04260160470228503-16-20The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking platelet contribution to the clot firmness. fib-tem®SThe FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking platelet contribution to the clot firmness. fib-tem®S The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking platelet contribution to the clot firmness. fib-tem®S is always used in conjunction with ex-tem®S. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF).is always used in conjunction with ex-tem®S. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MC 是 否 否
04260160470235503-19-20The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. The hep-tem® assay is a semi-quantitative in vitro diagnostic assay used to inactivate heparin in patients receiving unfractionated heparin on the ROTEM® delta. To monitor the coagulation process citrated whole blood specimens are used. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) a 是 否 否
04260160470242503-05The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF). 否 否 否
04260160470587000201014The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. CLOSE 否 否 否
04260160470044503-02The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. The in-tem® assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x 否 否 否
04260160470068503-04The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. ap-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF). 否 否 否
04260160470075503-06The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking platelet contribution to the clot firmness. fib-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF). 否 否 否
04260160470082503-09The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. The hep-tem® assay is a semi-quantitative in vitro diagnostic assay used to inactivate heparin in patients receiving unfractionated heparin on the ROTEM® delta. To monitor the coagulation process citrated whole blood specimens are used. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) a 否 否 否
04260160470099503-10The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve – clot firmness over time) and several defined numerical parameters describing the curve quantitatively. The star-tem® reagent is intended for use as recalcification reagent in the NATEM and INTEM assay on the ROTEM® delta. The corresponding assays are described in the NATEM assay application sheet and in the Instructions for Use of the in-tem® reagent (REF 503-02-US), resp. 否 否 否
04260160470105503-24ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only. 否 否 否
04260160470112503-25ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only. 否 否 否
04260160470136400041The pipette tips are used for test that The ROTEM delta system measures the qualitative and quantitative coagulation status of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The ROTEM system records kinetic changes of clot formation, retraction and lysis in a citrated whole blood sample 是 否 否
04260160470150200011The cup and pin is used for test that The ROTEM delta system measures the qualitative and quantitative coagulation status of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The ROTEM system records kinetic changes of clot formation, retraction and lysis in a citrated whole blood sample 是 否 否
04260160470198503-12-20The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. The in-tem® Sassay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). 是 否 否

找的不是這個型號？

可改用包裝上的完整型號或許可證字號查詢。