MEDCHECK許可證索引
衛部醫器輸字
許可證編號030466
許可證編號030466
輸入器材
醫療器材許可證 ／ 輸入器材
羅丹”西格瑪”全血血栓彈性分析系統
Rotem”Sigma” whole blood Thromboelastometry system
衛部醫器輸字第030466號
本站收錄狀態核准有效
有效日期2027 / 11 / 28
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 5 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
- 衛部醫器輸字第030466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
- 2017 / 11 / 28
- 有效日期
- 2027 / 11 / 28
- 限制項目
- 輸 入
- 資料異動日期
- 2022 / 12 / 08
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
- 本產品採用全自動化操作，搭配專用試劑，進行全血凝檢測結果。本產品可同時提供全血血液檢體中定量及定性的凝血狀態。記錄含有檸檬酸(Citrated)之全血，由流動狀態變為凝膠狀態、緊縮至血塊溶解的過程。經由量測、分析、監測、繪製成圖表，血塊的形式和參數，呈現受檢者的凝血機制結果。
- 規格
- 211000-EN、555501、555502、555201、555202， 以下空白。
製造廠
- 製造商
- TEM INNOVATIONS GMBH
- 國別
- 德國
- 廠址
- MARTIN-KOLLAR-STRASSE 15 .81829 MUNICH, GERMANY
- 製造許可登錄編號
- QSD12748
UDI 型號 共 5 筆
| 基本 DI | 型號 | 產品描述 | 單次使用 | 乳膠 | DEHP |
|---|---|---|---|---|---|
| 04260160470310 | 555501 | The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses. Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. | 是 | 否 | 否 |
| 04260160470327 | 555502 | The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses. Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. | 是 | 否 | 否 |
| 04260160470341 | 555201 | The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses. Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. | 是 | 否 | 否 |
| 04260160470358 | 555202 | The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses. Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. | 是 | 否 | 否 |
| 04260160470372 | 211000-EN | The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses. Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. | 否 | 否 | 否 |
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