Diode laser system approved by FDA, Medical CE certification!

In China market, no more than 10pcs companies have the FDA and Medical CE together!
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Medical CE certification: Now some European countries, such as Germany, Italy, Spain, the Netherlands, and Poland, will list beauty equipment as medical equipment. If there is no Medical CE, they will not be allowed to import.Even if the customs did not check and release it, the local government would not allow it to be used.
FDA: in USA, if no FDA, they can’t use machine, distributor also can’t sell machine in USA. why need FDA?  The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

here machines are approved by FDA and Medical CE certification

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Because we have the Medical CE certification, our beauty machines can be successfully sold to European countries, for eaxmple Germany, Italy, Spain, the Netherlands, and Poland, it is no problem for us. The distributors can also sell according to theMedical CE certification, and beauty salons or clinic, or doctor or spa can Legal use in  their local  under the Medical CE certification .
Because we have the FDA, our beauty machines can be successfully sold to the United States without any problems at customs. The USA distributor are very legal to sell beauty machines in the USA market, our USA customers , such as beauty salons or clinic, or doctor or spa are also legal to use it locally.

Legal use and sale is on the one hand, on the other hand Medical CE certification and FDA is very very different to apply. It is the 2 most strict and hard to get certifications, it is need souble inspect and ensure machine quality and factory quality control!

 

 

 


Post time: Jan-18-2022