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How to distinguish Class I, Class II and Class III medical devices

date:[2022-08-26 16:50:46]

Although many people are not unfamiliar with medical equipment, they do not know too much about it. Many doctors have also asked customer service managers: what kind of medical equipment are your instruments? What kinds of consumables are there? The four-meridian integrated medium frequency therapeutic instrument belongs to the second class of medical devices, and the consumables belong to the first class of medical devices. The relevant records and qualifications will be distributed with the products. Class III medical devices are the highest level of medical devices and must be strictly controlled. They refer to the medical devices implanted in the human body to support and maintain life, which are potentially dangerous to the human body, and their safety and effectiveness must be strictly controlled. Let's learn about it together!

Class I medical instrument 

 The first type of medical devices with low risk and routine management can ensure their safety and effectiveness. Such as: surgical instruments (knife, scissors, forceps, tweezers, hook), scraping board, medical X-ray film, surgical clothes, surgical caps, examination gloves, gauze bandages, drainage bags, etc.


Class II medical instrument 

The second type of medical devices have moderate risk and need strict control and management to ensure their safety and effectiveness. Such as: medical suture needle, blood pressure monitor, thermometer, electrocardiogram machine, electroencephalogram machine, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, non-absorbable suture, condoms, etc. (Four-meridian integrated medium frequency therapeutic instrument belongs to the second class)


Class III medical devices 

The third category is the medical devices with high risk, which need special measures to strictly control and manage to ensure their safety and effectiveness. Such as: implantable cardiac pacemaker, contact lens, intraocular lens, ultrasound tumor focusing knife, hemodialysis device, implant equipment, vascular stent, comprehensive anesthesia machine, dental implant materials, medical absorbable suture, intravascular catheter, etc.


Contact Us

Tel: +86-530-4660062
Mobile: +86-13105409308
E-mail: info@suturescn.com
Tianfu Roud, Dongcheng District,Shan County, Heze City, Shandong, China 274300

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