Both NB (SGS and TUV) tell us that our product is a class Im, and we follow the Annex IV according with the directive indications. [IMG] This...
Thank you for your response. We just on the middle on our certification with SGS company, we are in the middle of mechanical and security tests....
Hello Ronen E, What do you mean exactly with the differents between intervention on class Im and IIa ? Thank you
Thank you. We supposed the same. Yes, is correct that previous similar products like the IRx3 was classified as class IIa, but I think that now...
Hello: In my company we are developing a medical device similar like an aberrometer. We after read a lot of times the MDD 93/42/ECC we thought...
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