Zowunikira zisanu ndi chimodzi zapamwamba zamagazi zochokera ku Joytech Healthcare's DBP Plus zapatsidwa chilolezo cha FDA 510(k) pansi pa K261394, zomwe zikuthandizira kutsatsa pamsika waku US.
Kwa otsatsa azaumoyo komanso ogulitsa omwe akugwira ntchito pamsika waku US, chilolezochi sichitha kuwongolera - ndichothandiza kwambiri polowera msika. Chida chilichonse choyeretsedwa chidawunikidwanso ngati chida chachipatala cha Class II ndipo chapezeka kuti chikufanana kwambiri ndi maulosi ogulitsidwa mwalamulo, chomwe chimagwiritsidwa ntchito kukhudza anthu onse.
Mzere Woyeretsedwa wa Mitundu Sikisi Yatsopano
Mndandanda wa DBP Plus umabweretsa zitsanzo zisanu ndi chimodzi zatsopano ku Joytech Healthcare's US-cleared portfolio: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, ndi DBP-62E2B Plus.
Mtundu uliwonse umakhala wodziwikiratu makina opangira kuthamanga kwa magazi omwe amapangidwa kuti aziyeza kunyumba tsiku ndi tsiku. Mndandandawu ukupitirizanso mzere wovomerezeka wovomerezeka - omwe adatsogolera DBP-6186 ndi DBP-6286B adayeretsedwa ndi FDA mu 2025 kwa ogwiritsa ntchito mikono yayikulu, ndipo m'badwo wa Plus umakulitsa nsanja yofananira yomweyi kumitundu yotakata.
Makulidwe Awiri a Cuff, Kufalikira Kwambiri kwa Ogwiritsa
Mtundu uliwonse mu batchi umapangidwa ndi imodzi mwazosankha ziwiri za makafi - wokhazikika wa 22-42 cm kapena wotalikirapo wamkono wa 40-56 cm.
Njira ya anthu awiriwa ndi yofunika kwambiri pazamalonda monganso zachipatala. Imalola mapologalamu ogulitsa ndi ogula kuti apange mitundu yosiyanasiyana yophatikizira kuchokera kubanja limodzi lopangidwa, kotero kuti akuluakulu omwe mikono yawo imagwera kunja kwa ma cuff okhazikika asakakamizedwenso kuyeza.
Komwe Ma Monitor Awa Amakhala mu Portfolio yaku US
Kwa ogula akuwunika mndandanda wa DBP Plus, mfundo zitatu zikuwonekera:
Gulu lathunthu lamitundu isanu ndi umodzi limaphimbidwa ndi chilolezo chimodzi cha FDA 510 (k), kotero kukonzekera kwamitundu yosiyanasiyana kumatha kupitilira popanda mipata yoyendetsera mtundu uliwonse.
Mitundu yonse yokhazikika komanso yayikulu ya cuff ya mkono imapezeka mkati mwa malo oyeretsedwa.
Chiwonetsero cha kuchuluka kwa anthu chimathandizira mipata yambiri yogawa ku US, kuphatikiza malonda, e-commerce, ndi njira zina zamankhwala.
Mbiri yovomerezeka yokha imatha kutsimikiziridwa ndi othandizana nawo panthawi yachangu - chidule cha K261394 chikupezeka poyera kudzera mu nkhokwe ya FDA.
Zomangidwa pa Regulatory Track Record Yokhazikitsidwa
Chilolezochi chikuwonjezera chiwongola dzanja cha US ku Joytech Healthcare, chomwe chikuphatikiza kale zilolezo 510 (k) zowunikira kuthamanga kwa magazi ndi njira zowunikira shuga wamagazi, kuphatikiza chizindikiro cha CE pansi pa EU MDR, certification ya ISO 13485, ndi kutsata kwa MDSAP.
Kwa ogwirizana nawo a OEM/ODM, mbiriyo ifupikitsa zokambiranazo: funso limachoka ngati wopanga angakwaniritse zomwe US amafuna kuti ndi mtundu wanji womwe ungagwirizane ndi pulogalamuyo.
Ikupezeka pa Kugawa ndi Mapulogalamu a OEM/ODM
Joytech Healthcare pakali pano ikuvomereza zopempha kuchokera kwa ogulitsa zipangizo zachipatala ku US, ogulitsa kunja, ndi ogulitsa malonda omwe ali ndi chidwi ndi mndandanda wa DBP Plus - kuphatikizapo chitukuko cha label-label, kulongedza mwambo, ndi zothandizira zolemba zolembera msika.
Za Joytech Healthcare
Joytech Healthcare ndi katswiri wopanga chithandizo chamankhwala kunyumba ndi zida zowunikira zamankhwala, okhazikika pazowunikira kuthamanga kwa magazi, ma thermometers, pulse oximeters, nebulizers, mapampu am'mawere ndi zinthu zina zamankhwala.
Timapereka Mayankho a zida zachipatala za OEM/ODM pama brand azachipatala padziko lonse lapansi, ogawa, ndi othandizana nawo, kuyang'ana kwambiri kutsata malamulo, kudalirika kwazinthu, komanso mgwirizano wanthawi yayitali.
Kuti mupemphe zitsanzo zowunika, zolemba zovomerezeka, kapena mtengo wogulira pagulu la DBP Plus, fikani ku gulu lathu ku. sale14@sejoy.com - kapena sakatulani mndandanda wathunthu wa FDA 510(k) wochotsa kuthamanga kwa magazi patsamba lathu.
