Ngomhla wama-21 kuJuni, ngo-2017, i-FDA ibhengeze i-14^thisaziso somgangatho wezixhobo zonyango kunye nolawulo lomgangatho olupapashweyo kunye nemeko yokuhlolwa kwesampulu yeendidi ezi-3 Iiseti ezingama-247 iimveliso ezifana neetyhubhu ze-tracheal ezilahlwayo, i-thermometer ye-elektroniki yezonyango njl.njl.

Iisampulu ezihlolwe ngokungacwangciswanga ezingafikeleliyo kwimigangatho yezixhobo zonyango ezibandakanya iindidi ezi-3 Iiseti ezi-4 zeemveliso eziveliswe ngabenzi bezixhobo zonyango ezi-4; izinto ezihlolweyo ezifana nokuchongwa kweelebheli, iincwadana njl.njl. ezingafikeleliyo kwimigangatho zezodidi olu-1 Iiseti ezi-2 zezixhobo zonyango eziveliswe ngabenzi bezixhobo zonyango ezi-2; Iindidi ezi-3 Iiseti ezingama-241 zezixhobo zonyango eziveliswe ngabenzi bezixhobo zonyango abangama-92 abahlangabezana nemigangatho efanelekileyo kuzo zonke izinto ezihlolweyo.

Okwangoku, i-Food and Drug Administration yesizwe sele icele amasebe olawulo lokutya kunye namayeza asekuhlaleni ukuba aphande aze ajongane namashishini afanelekileyo, kwaye icele amasebe olawulo lokutya kunye namayeza afanelekileyo ukuba abhengeze ukupheliswa kwale meko kuluntu.

Ukuze komelezwe ukubekwa esweni nokulawulwa komgangatho wezixhobo zonyango nokuqinisekisa ukusetyenziswa ngokukhuselekileyo nangokufanelekileyo kwezixhobo zonyango, i-FDA yethu kazwelonke kutshanje yenza ukubekwa esweni komgangatho kunye nokuthathwa kweesampuli ngokuhambelana ngokuchanekileyo nokuphindaphindiweyo ukuya kuthi ga kumyinge wezihlandlo ezi-2 ngenyanga. Oku kubonisa ngokupheleleyo inkxalabo karhulumente ngezixhobo zonyango, kufuneka umelane novavanyo lwemarike ukuba ufuna ukuqhubeka nale ndlela.

I-Shenzhen Med-link Medical Electronics Co., Ltd. isoloko ifuna ukuba zonke iimveliso zihlangabezane nemigangatho yamva nje yesizwe neyehlabathi. Ekubeni yasekwa ngo-2004, emva konyaka omnye wokuceba, iqela lokuqala le-Med-link leentambo ze-ECG kunye neentambo ze-lead liphumelele ubhaliso lwe-CFDA ngempumelelo, sisiqalo esihle kwaye sikwabubungqina obuhle bemizamo yethu.

Emva kophando olutsha lweminyaka eli-13 kwicandelo lezixhobo zonyango ngo-2017, i-Med-link's yaphuhlisa ngokuzimeleyo i-temperature probe, i-SpO₂ sensor ephinda isetyenziswe, ipensile ye-ESU elahlwayo, intambo yokwandisa i-pulse SpO₂, i-brain electrode engangenisi, intambo ye-IBP njl.njl., zonke ezi mveliso ziqinisekiswe ngokusemthethweni yimibutho yamazwe ngamazwe efana ne-CFDA, i-FDA, i-CE njl.njl.

Ngenxa yamava avavanyiweyo kwimarike yezixhobo zonyango, asiyi kuzifica kwixesha elidlulileyo, kwaye asiyi kuthatha inyathelo ngenyathelo. Ngokuziqhelanisa nemarike yezixhobo zonyango etshintsha rhoqo, ukuhlangabezana neemfuno zamva nje zamaqela ahlukeneyo, i-Med-link Medical iya kuhlala ilandela imigangatho ephezulu kunye netekhnoloji ephezulu, kwaye ibonakalise amandla ethu ngomgangatho wemveliso.

Ukudibanisa ukhathalelo lobomi nokhathalelo, kwenza abasebenzi bezonyango babe lula, abantu babe sempilweni!