Uhlelo lwe-laser ye-Diode luvunywe yi-FDA, isitifiketi se-Medical CE!

Emakethe yaseChina, akukho zinkampani ezingaphezu kuka-10pcs ezinazoI-FDA kanye ne-Medical CEndawonye!
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Isitifiketi se-Medical CE: Manje amanye amazwe aseYurophu, njengeJalimane, i-Italy, iSpain, iNetherlands, nePoland, azoklelisa izinto zobuhle njengemishini yezokwelapha.Uma ingekho i-Medical CE, ngeke bavunyelwe ukuthi bangenise kwamanye amazwe.Ngisho noma intela ayizange ihlole futhi ikhishwe, uhulumeni wendawo ngeke avume ukuthi isetshenziswe.
I-FDA: e-USA, uma kungekho FDA, abakwazi ukusebenzisa umshini, umsabalalisi naye akakwazi ukuthengisa umshini e-USA.kungani udinga i-FDA?I-Food and Drug Administration inesibopho sokuvikela impilo yomphakathi ngokuqinisekisa ukuphepha, ukusebenza kahle, nokuvikeleka kwezidakamizwa zabantu nezilwane, imikhiqizo yebhayoloji, kanye nemishini yezokwelapha;kanye nokuqinisekisa ukuphepha kokutholakala kokudla kwesizwe sakithi, izimonyo, nemikhiqizo ekhipha imisebe.

lapha imishini ivunywe yi-FDA kanye nesitifiketi se-Medical CE

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I-LD1Y-C(1)

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Ngenxa yokuthi sinesitifiketi se-Medical CE, imishini yethu yobuhle ingathengiswa ngempumelelo emazweni aseYurophu, ngokwesibonelo iJalimane, i-Italy, iSpain, iNetherlands, nePoland, akuyona inkinga kithi.Abasabalalisi bangaphinda bathengise ngokuya ngesitifiketi se-Medical CE, namasaluni noma umtholampilo, noma udokotela noma i-spa Ingasetshenziswa ngokusemthethweni endaweni yabo ngaphansi kwesitifiketi se-Medical CE.
Ngenxa yokuthi sine-FDA, imishini yethu yobuhle ingathengiswa ngempumelelo e-United States ngaphandle kwezinkinga ezinkambisweni.Abasabalalisi base-USA basemthethweni kakhulu ukuthengisa imishini yobuhle emakethe yase-USA, amakhasimende ethu ase-USA , njengamasaluni noma umtholampilo, noma udokotela noma i-spa nakho kusemthethweni ukukusebenzisa endaweni.

Ukusetshenziswa okusemthethweni nokudayiswa ngakolunye uhlangothi, ngakolunye uhlangothi isitifiketi se-Medical CE kanye ne-FDA yehluke kakhulu ukusebenzisa.Ingu-2 eqinile futhi enzima kakhulu ukuthola izitifiketi, idinga ukuhlolwa okunenhliziyo nokuqinisekisa ikhwalithi yomshini nokulawula ikhwalithi yefekthri!

 

 

 


Isikhathi sokuthumela: Jan-18-2022