Electronic thermometers need to be device approval

1, first of all, the electronic thermometer is a class 2 medical device, so you need a device license, that is, approval number.

2, see the "Medical Device Classification Catalog": code code 6820 general diagnostic instruments: Classification No. 6820-01;

Management category Class II

Name examples: electronic thermometer, infrared cochlear thermometer, oral, anal, axillary thermometer, skin thermometer, liquid crystal thermometer are Class 2 devices.

3, according to the provisions of the "Medical Device Classification Catalog" of products managed by medical devices, electronic thermometers have been included in the Class 2 medical devices, so you must apply for the approval of medical devices, that is, the device quasi.

4, if the product does not have the approval number, is not available for sale, if the sale of medical devices according to the sale of no proof of product registration.