Class I medical devices: band-aid such, external, non-sterile.
Class II medical devices: aseptic cleanroom production of some supplies, such as infusion tubes, sterile masks
Class III medical devices: implantable high-value supplies, such as cardiac stents, bone nails.
You uploaded the attachment is a class II business license and a production license
Operation of a class of medical devices: no need to record, the business license has a class of business logo
Operation of a class of medical devices: need to be filed, in layman's terms, that is, to tell the Market Supervision Bureau a, I'm in the operation of the second class of products.
Medical equipment class III: need to be approved for licensing, take the business license, in general terms, is to tell the market supervision bureau I want to operate three types of medical equipment, the Supervisory Board will carry out door-to-door investigation to see if you have the ability to operate. If there is no problem will give you approval through.
Production of a class of: need to have a product filing certificate, that is, I am allowed to market this product market regulatory bureau
Production of two class three: need to have a product registration certificate and production license, that is, I have aseptic production conditions and my products are allowed to market market
So if you want to produce, masks are not sterile at least filing certificates, the amount of temperature gun is not sterile is also have to have at least a certificate of filing.
If the mask is medical sterile, it is a class II product, the right number needs to have a registration certificate and production license