Su Mechanical Note Approval means: Class II medical devices under the jurisdiction of Jiangsu.
State word for the device: State Mechanical Note Approval - belongs to the third class of medical devices, product registration and approval are managed by the State Drug Administration. The state apparatus note permitted: the territory of the production of Class III medical devices; state apparatus note into: imported two or three classes of medical devices; state apparatus note licensed: Hong Kong, Macao and Taiwan introduced two or three classes of medical devices; state apparatus ready: imported a class of medical devices.
Take Jiangsu and Suzhou as an example of local medical devices: Su mechanical injection permit: Jiangsu jurisdiction of the second class of medical devices; Su Su mechanical preparation: Suzhou jurisdiction of the first class of medical devices.
Medical device registration certificate number meaning: to the state mechanical note quasi 20223408888 as an example, 2022 is the year number, this device is approved for registration in 2022; 3 is the device management category, this device is a class 3 medical device; 40 is the classification of the device code category, this device belongs to the in vitro diagnostic reagent class of products; 8888 is a four-digit streaming number, proving that it is your The 8888th person to get the certificate of registration in this year.
Mechanical Product Classification
Mechanical products are used on the human body surface and in the body of the utility through physical and other means, not through pharmacology, immunology or metabolism, but there may be these means of participation and play a certain role in assisting. The purpose of its use includes: the prevention, diagnosis, treatment, monitoring, alleviation of disease; diagnosis, treatment, monitoring, alleviation, compensation for injury or disability; the study of anatomical or physiological processes, substitution, regulation; pregnancy control and so on.
Medical devices are divided into three categories: the first category refers to medical devices whose safety and effectiveness are sufficiently ensured through routine management, such as masks, band-aids, surgical instruments, etc. The second category refers to medical devices whose safety and effectiveness are sufficiently ensured through routine management. The second category refers to the safety and effectiveness of medical devices should be controlled, such as blood pressure monitors, blood glucose meters, saline solution therapeutic instrument.
The third category refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices, such as disposable sterile syringes / infusion sets, vascular stents, artificial organs.