Overview | 合法醫療器材資訊網
![Overview](https://i.imgur.com/6y29Lx7.jpg)
Legislation.TheEuropeanregulatoryframeworkensuresthesafetyandefficacyofmedicaldevicesandfacilitatespatients'accesstodevicesintheEuropean ...
![Overview](https://i.imgur.com/6y29Lx7.jpg)
Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
The EU has a competitive and innovative medical devices sector, characterised by the active role of small and medium-sized enterprises. It is supported by a regulatory framework that aims to ensure the smooth functioning of the internal market, taking as a base a high level of protection of health for patients and users.
There are over 500 000 types of medical devices and IVDs on the EU market. Examples of medical devices are sticking plasters, contact lenses, X-ray machines, pacemakers, breast implants, software apps and hip replacements. IVDs are used to perform tests on samples, and examples include HIV blood tests, pregnancy tests and blood...
Download MDR | 合法醫療器材資訊網
Getting ready for the new regulations | 合法醫療器材資訊網
MDCG endorsed documents and other guidance | 合法醫療器材資訊網
Medical Device Regulation comes into application | 合法醫療器材資訊網
Medical devices | 合法醫療器材資訊網
New Regulations | 合法醫療器材資訊網
Overview | 合法醫療器材資訊網
REGULATION (EU) 2020561 OF THE EUROPEAN ... | 合法醫療器材資訊網
The European Union Medical Device Regulation – Regulation ... | 合法醫療器材資訊網
![](https://i.imgur.com/6y29Lx7.jpg)
【外科用鐳射裝置】許可證字號:衛署醫器輸字第006881號
器材品名:外科用鐳射裝置許可證字號:衛署醫器輸字第006881號註銷狀態:已註銷註銷日期:2007/07/23註銷理由:許可證已逾有效期...
![](https://i.imgur.com/6y29Lx7.jpg)
【“艾微醫學”艾微改藍二代導引導管】許可證字號:衛部醫器輸字第027607號
器材品名:“艾微醫學”艾微改藍二代導引導管許可證字號:衛部醫器輸字第027607號註銷狀態:註銷日期:註銷理由:有效日期:2020/08/...
![](https://i.imgur.com/6y29Lx7.jpg)
【立適美 牙科手術裝置及其附件 (未滅菌)】許可證字號:衛署醫器製壹字第004328號
器材品名:立適美牙科手術裝置及其附件(未滅菌)許可證字號:衛署醫器製壹字第004328號註銷狀態:已註銷註銷日期:2019/12/13註銷...
![](https://i.imgur.com/6y29Lx7.jpg)
【"音桐美迪"手動式眼科手術器械(未滅菌)】許可證字號:衛部醫器輸壹字第014149號
器材品名:"音桐美迪"手動式眼科手術器械(未滅菌)許可證字號:衛部醫器輸壹字第014149號註銷狀態:註銷日期:註銷理由:有效日期:...
![](https://i.imgur.com/6y29Lx7.jpg)
【艾微視心血管攝影導管】許可證字號:衛署醫器輸字第023492號
器材品名:艾微視心血管攝影導管許可證字號:衛署醫器輸字第023492號註銷狀態:註銷日期:註銷理由:有效日期:2022/05/03發證日期...
![](https://i.imgur.com/6y29Lx7.jpg)
【“嵩和” 電動式外科手術檯(未滅菌)】許可證字號:衛部醫器製壹字第008018號
器材品名:“嵩和”電動式外科手術檯(未滅菌)許可證字號:衛部醫器製壹字第008018號註銷狀態:註銷日期:註銷理由:有效日期:2024/1...
![](https://i.imgur.com/6y29Lx7.jpg)
【“恆隆行”軀幹裝具 (未滅菌)】許可證字號:衛署醫器製壹字第002652號
器材品名:“恆隆行”軀幹裝具(未滅菌)許可證字號:衛署醫器製壹字第002652號註銷狀態:已註銷註銷日期:2018/04/25註銷理由:許可...
![](https://i.imgur.com/6y29Lx7.jpg)
【"瑞濤" 電動吸鼻器 (未滅菌)】許可證字號:衛部醫器輸壹字第018551號
器材品名:"瑞濤"電動吸鼻器(未滅菌)許可證字號:衛部醫器輸壹字第018551號註銷狀態:註銷日期:註銷理由:有效日期:2022/11/28發...
![](https://i.imgur.com/6y29Lx7.jpg)
【健資動態血壓監測系統】許可證字號:衛部醫器輸字第025448號
器材品名:健資動態血壓監測系統許可證字號:衛部醫器輸字第025448號註銷狀態:註銷日期:註銷理由:有效日期:2023/11/04發證日期...
![](https://i.imgur.com/6y29Lx7.jpg)
【"安施" 非動力式神經外科用器械 (未滅菌)】許可證字號:衛部醫器輸壹字第014541號
器材品名:"安施"非動力式神經外科用器械(未滅菌)許可證字號:衛部醫器輸壹字第014541號註銷狀態:註銷日期:註銷理由:有效日期:...
![](https://i.imgur.com/6y29Lx7.jpg)
【超音波治療器】許可證字號:衛署醫器輸字第007172號
器材品名:超音波治療器許可證字號:衛署醫器輸字第007172號註銷狀態:已註銷註銷日期:2007/07/30註銷理由:許可證已逾有效期有...
![](https://i.imgur.com/6y29Lx7.jpg)
【經鼻式陽壓呼吸器】許可證字號:衛署醫器輸字第007840號
器材品名:經鼻式陽壓呼吸器許可證字號:衛署醫器輸字第007840號註銷狀態:已註銷註銷日期:2007/08/28註銷理由:許可證已逾有效...
![](https://i.imgur.com/6y29Lx7.jpg)
【"怡貝明" 醫學影像傳輸裝置 (未滅菌)】許可證字號:衛部醫器製壹字第006085號
器材品名:"怡貝明"醫學影像傳輸裝置(未滅菌)許可證字號:衛部醫器製壹字第006085號註銷狀態:註銷日期:註銷理由:有效日期:2021...
![](https://i.imgur.com/6y29Lx7.jpg)
【“健資”中心動脈壓及脈搏波分析系統】許可證字號:衛署醫器輸字第024973號
器材品名:“健資”中心動脈壓及脈搏波分析系統許可證字號:衛署醫器輸字第024973號註銷狀態:註銷日期:註銷理由:有效日期:2023/0...
![](https://i.imgur.com/6y29Lx7.jpg)
【"鎂町" 麻醉氣體面罩 (未滅菌)】許可證字號:衛部醫器輸壹字第017107號
器材品名:"鎂町"麻醉氣體面罩(未滅菌)許可證字號:衛部醫器輸壹字第017107號註銷狀態:註銷日期:註銷理由:有效日期:2021/10/21...