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FAQ 3. We need CE certificate.



HIT 3,416

DATE July 03, 2014

Q. We need CE certificate

For CE, we can’t acquire it.  I beg to inform the reason.

We're receiving same requests from our several buyers in EU before.

So, we contacted international professional consultant regarding CE.

In conclusion, sticky mat is not applied to medical device.  So, there is no need CE certificate and also can’t do CE marking.  Maybe, I think you saw or heard that your competitor has CE marking.

If yes, CE marking is against law.  It’s not CE certificate.  It’s just self-declaration of conformity.

As I kindly informed, sticky mat is not applied to medical device.  So it’s impossible self-declaration of conformity.  Namely, these documents are not valid and meaningless. 

So, if you need self-declaration like your competitor, we can make it same as them and send if you advice detailed documents form.

But, please remember these documents are illegal according to our consultant.  So, we can’t guarantee it.   

If you have doubt, you can ask your country’s professional consultant directly.

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