Malunga

I-Shanghai Mekon Medical Devices Co., Ltd. yasungulwa ngo-2009 kwaye izinikele ekuboneleleni ngezisombululo ezenzelwe wena kwiintlobo ngeentlobo zeemveliso ezahlukeneyo. iinaliti zonyango ezikhethekileyo, ii-cannula, iimveliso zesinyithi zonyango ezichanekileyokunye izinto ezahlukeneyo ezisetyenziswayo kwezonyango yenzelwe ngokukodwa iinaliti kunye nee-cannula. Inkqubo yethu epheleleyo yemveliso ibandakanya ukuwelda iityhubhu, ukuzoba iityhubhu, umatshini wokulungisa, ukucoca, ukupakishwa, kunye nokubulala iintsholongwane. Sisebenzisa izixhobo eziphambili ezingeniswe eJapan nase-United States ukuqinisekisa umgangatho kunye nozinzo lwemveliso yethu. Ukongeza, siphuhlise izixhobo zokucubungula ezikhethekileyo ukuhlangabezana neemfuno zemveliso ezizodwa zabathengi bethu.

Ingubo izimisele kwimigangatho ephezulu yomgangatho, ukuthobela imithetho, kunye nokugqwesa kwemithetho. Inkqubo yethu yolawulo lomgangatho eqinileyo ibonakaliswa yipotifoliyo epheleleyo yeziqinisekiso kunye neemvume ezidumileyo zamazwe ngamazwe, ukuqinisekisa ukuba iimveliso zethu ziyahlangabezana neemfuno zemarike yehlabathi:

• Uphawu lwe-CE: Ukuze kuhambelane nemigangatho yaseYurophu yempilo, ukhuseleko, kunye nokhuseleko lokusingqongileyo.

• I-ISO 13485: Isiqinisekiso seNkqubo yethu yoLawulo loMgangatho weZixhobo zonyango.

• Isigunyaziso se-FDA 510(k) (e-USA): Ukubonisa ukhuseleko nokusebenza kakuhle kwezixhobo zethu kwimarike yaseMelika.

• I-MDSAP (Inkqubo yoHlolo lweSixhobo sezonyango esisodwa): Ukuthobela imithetho kwiindawo ezahlukeneyo (kuquka i-USA, iKhanada, iOstreliya, kunye neBrazil).

• I-TGA (eOstreliya): Imvume yokungena kwimarike e-Australia.