台灣醫療器材
許可證資料查詢
MEDCHECK許可證索引
衛部醫器輸字
許可證編號035301
輸入器材
醫療器材許可證 ／ 輸入器材

“擅特克”數位監測系統

“SenTec” Digital Monitoring System (SDMS)

衛部醫器輸字第035301號
本站收錄狀態核准有效
有效日期2032 / 02 / 09
醫療器材級數第二等級

申請商為 博兆股份有限公司，收錄 31 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035301號
申請商
博兆股份有限公司 （查看此申請商全部許可證）
統一編號
84103959
申請商地址
新北市淡水區中正東路二段29號16樓
發證日期
2022 / 02 / 09
有效日期
2032 / 02 / 09
限制項目
輸 入
資料異動日期
2026 / 09 / 16

這類器材是什麼 皮膚表面氧氣監視器(非侵入式)，AI 輔助整理

皮膚表面氧氣監視器是一種貼在皮膚上、不扎針就能持續看血中氧氣變化的儀器，官方分類屬於麻醉科學下的「皮膚表面氧氣監視器（非侵入式）」。

它跟一般血氧機差在哪

兩者都不扎針，但原理和用途不同。一般指尖血氧機是用光穿透手指推算血氧，多半用在病房、居家監測；這類經皮式監視器是把加熱的電極貼在皮膚上，讓局部血流增加，再直接量測從皮膚擴散出來的氧氣，可以連續、即時看到變化，通常用在需要密集追蹤的醫療情境。

誰會用到它

這是醫療院所使用的設備，不是民眾自己買回家用的器材。常見於手術麻醉、加護病房或新生兒照護等需要持續監測的場合，由醫療人員操作與判讀。

怎麼確認是合法的

這類產品在台灣屬於第 2 等級醫療器材，本站收錄的有效許可證只有 4 張，全部是進口，製造廠分別在丹麥、瑞士等地。包裝或機身要能看到醫療器材許可證字號，格式像「衛部醫器輸字第○○○○○○號」，拿到字號可以在本站查是否仍有效。

使用上的常識

  • 電極貼片要貼在血流充足、皮膚完整的部位，實際位置由醫療人員依情況決定。
  • 貼片會加熱皮膚，長時間使用要留意局部皮膚狀況。
  • 機器需要定期校正與保養，這部分由醫療院所依原廠說明執行。
  • 數值要搭配其他臨床資訊一起看，單一讀數不能直接當成診斷。

常見問題

皮膚表面氧氣監視器可以帶回家自己用嗎？

不行。這類設備需要專業操作、校正與判讀，通常只在醫療院所使用。居家要監測血氧，一般會用指尖血氧機，是否需要、怎麼用，依醫師指示。

它跟抽血驗血氧有什麼不同？

抽血是單次採樣，得到的是當下那一刻的數值；皮膚表面氧氣監視器是貼在皮膚上連續監測，可以看到氧氣隨時間的變化趨勢，適合需要持續觀察的情況。

貼片會不會傷皮膚？

不一定。貼片運作時會加熱皮膚以增加局部血流，短時間使用通常沒問題，但長時間或皮膚較敏感的人可能出現發紅或不適，醫療人員會定期更換位置並檢查皮膚。

這個檢查會痛嗎？

不會。它是非侵入式的，不需要扎針，只是把電極貼片黏貼在皮膚上，過程中可能感覺到溫溫的，屬正常現象。

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
  • 滅菌包裝未填
  • 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
詳如核定之中文說明書
規格
詳如核定之中文說明書

製造廠

製造商
SENTEC AG
國別
瑞士
廠址
RINGSTRASSE 39, CH-4106 THERWIL, SWITZERLAND
製造許可登錄編號
QSD7694

UDI 型號 共 31 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
07640121880018SDMStand alone monitor with colour display for continuous non-invasive vital parameter monitoring, with integrated docking station for sensor storage and calibration. 否 否 否
07640121880032AC-150Adapter cable to connect SenTec TC Sensors to the SenTec Digital Monitor. 否 否 否
07640121880049EC-MIThe Ear Clip is required to attach SenTec TC Sensors to the patient’s earlobe. Suitable for patients with earlobes of sufficient size and mature, intact skin. 是 否 否
07640121880056GAS-0812The Service Gas is required for the calibration of the PCO2-part of SenTec TC Sensors. 否 否 否
07640121880070GEL-04The Contact Gel is required for proper CO2 gas conduction from the patient’s skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor membrane. 否 否 否
07640121880087MC-RThe membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC-R) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. To enable an economic and cost saving membrane change, the Membrane Changer after use can be reloaded with a new Membrane Changer Insert (MC-I). 否 否 否
07640121880162AC-250Adapter cable to connect SenTec TC Sensors to the SenTec Digital Monitor. 否 否 否
07640121880179AC-750Adapter cable to connect SenTec TC Sensors to the SenTec Digital Monitor. 否 否 否
07640121880223MAR-MIMAR-MI is intended to attach SenTec TC Sensors to various measurement sites for patients with mature, intact skin. 是 否 否
07640121880230MAR-SFMAR-SF is intended to attach SenTec TC Sensors to various measurement sites for patients with sensitive, fragile but intact skin. 是 否 否
07640121880506MC-IThe Membrane Changer (MC-R) is a reloadable tool to change the membrane of SenTec TC Sensors. Prior reuse, the Membrane Changer (MC-R) must be reloaded with a new Membrane Changer Insert (MC-I). The MC-I is single-use 是 否 否
07640121880513VS-A/P/NDigital Sensor for non-invasive and continuous measurement of transcutaneous carbon dioxide partial pressure and pulse oximetry. Suitable for adult, pediatric and neonatal patients. 否 否 否
07640121880742OV-A/P/NDigital Sensor for non-invasive and continuous measurement of transcutaneous carbon dioxide and oxygen partial pressure as well as pulse oximetry. Suitable for adult, pediatric and neonatal patients. 否 否 否
07640121880797MARe-MISingle use sensor application ring, recommended for adult, pediatric and neonatal patients with mature/intact skin 是 否 否
07640121880803MARe-SFSingle use sensor application ring, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin 是 否 否
07640121880889SDM_WPCThis cover will protect the SenTec Digital Monitor (SDM) from dripping water when the device is tilted up to 15° (IPX2). 否 否 否
07640121880896RFT100VA-V2Isolates the SDM from mains for use in home use environments. 否 否 否
07640121880902RFT100VA-V1Isolates the SDM from mains for use in home use environments. 否 否 否
07640121880933MCThe membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. The MC is single-use. 是 否 否
17640121880046EC-MIThe Ear Clip is required to attach SenTec TC Sensors to the patient’s earlobe. Suitable for patients with earlobes of sufficient size and mature, intact skin. 是 否 否
17640121880053GAS-0812The Service Gas is required for the calibration of the PCO2-part of SenTec TC Sensors. 否 否 否
17640121880220MAR-MIMAR-MI is intended to attach SenTec TC Sensors to various measurement sites for patients with mature, intact skin. 是 否 否
17640121880237MAR-SFMAR-SF is intended to attach SenTec TC Sensors to various measurement sites for patients with sensitive, fragile but intact skin. 是 否 否
17640121880503MC-IThe Membrane Changer (MC-R) is a reloadable tool to change the membrane of SenTec TC Sensors. Prior reuse, the Membrane Changer (MC-R) must be reloaded with a new Membrane Changer Insert (MC-I). The MC-I is single-use 是 否 否
17640121880794MARe-MISingle use sensor application ring, recommended for adult, pediatric and neonatal patients with mature/intact skin 是 否 否
17640121880800MARe-SFSingle use sensor application ring, recommended for adult, pediatric and neonatal patients with sensitive/fragile skin 是 否 否
17640121880862GEL-SDThe Contact Gel is required for proper CO2 gas conduction from the patient's Skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor Membrane. GEL-SD is delivered in single dose vials each containing 0.3 g of the solution and is intended for single use. 是 否 否
17640121880930MCThe membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. The MC is single-use. 是 否 否
27640121880081MC-RThe membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC-R) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. To enable an economic and cost saving membrane change, the Membrane Changer after use can be reloaded with a new Membrane Changer Insert (MC-I). 否 否 否
07640121880568SA-MARThe Staysite Adhesive (SA-MAR), is an optional, single-use adhesive which is indicated for use with Multi-Site Attachment Rings, if more secure attachment is required. 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。