1) For example, a class of medical devices Band-Aid, in its registration number "No. 1640428" in the "1" is the meaning of a class.
Class I medical devices are low-risk and can be managed routinely. In addition to Band-Aid, ordinary surgical scissors, hemostatic forceps, forceps, medical magnifying glass, negative pressure canisters, overhead hanger, hospital beds, ice packs, gauze bandages, rubber ointment, surgical gowns and hats, etc. belong to a class of medical equipment.
2) For example, class II medical device sphygmomanometer, in its registration number "No. 2201142" in the first "2" is the meaning of class II.
The risk level of Class II medical devices is moderate, requiring more stringent control management to ensure its effectiveness and safety. In addition to Band-Aids, thermometers, blood glucose meters, stethoscopes, electrocardiographic diagnostic instruments, vision meter boxes, vision examiners, acupuncture needles, pronged needles, medical cotton wool, medical gauze, medical cotton wool, thermostatic incubators and so on belong to the second class of medical devices.
3) such as Class III medical devices disposable infusion needles, in its registration number "No. 3150287" in the first "3" is the meaning of Class III.
Class III medical devices have a higher risk, need to take particularly strict control measures to ensure its effectiveness and safety. In addition to disposable infusion needles, implantable cardiac pacemakers, ocular IOLs, corneal contact lenses, electronic endoscopes, puncture needles, medical magnetic **** vibration imaging equipment, insulin pumps, interventional devices, a variety of preterm incubators, dental implantable materials, medical magnetic **** vibration imaging systems, and X-ray diagnostic and therapeutic equipment, such as CT machines, all belong to the second class of medical devices.
Legal basis:
"Measures for the Administration of Registration of Medical Devices" (Food and Drug Administration Decree No. 4), Chapter VI, Article 49 and "Code of Practice for Registration and Approval of Class III and Imported Medical Devices within the Territory" (Food and Drug Administration Mechatronics [2014] No. 208), the "Certificate of Registration of Medical Devices" and its annexes are listed as follows Registration of limited content, has been registered Class II, Class III medical devices, medical device registration certificate and its annexes set out in the content changes, the registrant shall apply to the original registration department for registration changes.