Indorerezi esheshatu zikoresha umuvuduko ukabije wamaraso ukomoka muri serivise ya DBP Plus ya Joytech Healthcare yahawe FDA 510 (k) yemewe na K261394, bituma ubucuruzi bwisoko ryamerika.
Kubirango byubuzima hamwe nababikwirakwiza bakora mumasoko yo muri Amerika, uku kwemererwa ntikurenze intambwe ngenderwaho - ni uburyo bwiza bwo kwinjiza isoko. Buri gikoresho cyakuweho cyasubiwemo nkigikoresho cy’ubuvuzi cyo mu cyiciro cya II ugasanga gihwanye cyane n’ibicuruzwa byemewe ku isoko byemewe n'amategeko, hagamijwe gukoreshwa bikubiyemo abaturage muri rusange.
Imirongo isukuye ya Moderi esheshatu nshya
Urukurikirane rwa DBP Plus ruzana moderi esheshatu nshya muri Joytech Healthcare yo muri Amerika yakuweho: DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, na DBP-62E2B Plus.
Buri cyitegererezo ni cyikora rwose monitor y'amaraso yo hejuru- yubatswe kugirango bapime urugo rwa buri munsi. Urukurikirane kandi rukomeza umurongo ugaragara - abayibanjirije DBP-6186 na DBP-6286B bahanaguwe na FDA mu 2025 kubakoresha bafite intwaro nini, kandi na generation ya Plus yongerera iyo tekinoroji imwe muburyo bwagutse.
Ingano ebyiri za Cuff, Umukoresha Mugari
Buri cyitegererezo mubice byashyizweho hamwe nuburyo bubiri bwa cuff - isanzwe ya cm 22-42 cuff cyangwa se cm 40-56 nini yagutse.
Ubu buryo bubiri bwibintu byingenzi mubucuruzi nkubuvuzi. Iremera gahunda yo kugurisha hamwe nabaguzi binzego kubaka ingano-yuzuye igizwe numuryango umwe wibicuruzwa bisukuye, kuburyo abantu bakuru bafite amaboko agwa hanze yumutambiko usanzwe batagihatirwa gupimwa.
Aho Aba Monitor bakwiranye na Portfolio yo muri Amerika
Ku baguzi basuzuma urutonde rwa DBP Plus, ingingo eshatu zigaragara:
Icyiciro cyuzuye-cyicyitegererezo cyuzuye kirimo FDA 510 (k), bityo igenamigambi rishobora gukomeza nta cyuho cyateganijwe.
Byombi bisanzwe kandi binini byamaboko ya cuff verisiyo iraboneka murwego rwagenwe.
Icyerekezo rusange cy’abaturage gishyigikira uburyo butandukanye bwo gukwirakwiza Amerika, harimo gucuruza, e-ubucuruzi, n’izindi nzira zita ku buzima.
Inyandiko yerekana neza ubwayo irashobora kugenzurwa nabafatanyabikorwa mugihe cyitondewe - incamake ya K261394 irashobora kuboneka kumugaragaro binyuze mububiko bwa FDA.
Yubatswe ku gitabo cyashyizweho gishinzwe kugenzura
Iki cyiciro cyo gukuraho cyiyongera ku nshingano z’Amerika ziyongera ku bijyanye n’ubuzima bwa Joytech Healthcare, isanzwe ikubiyemo 510 (k) mbere yo gukuraho abashinzwe umuvuduko w’amaraso hamwe na sisitemu yo gukurikirana amaraso ya glucose, hamwe n’ikimenyetso cya CE cyashyizweho na EU MDR, icyemezo cya ISO 13485, hamwe na MDSAP.
Ku bafatanyabikorwa ba OEM / ODM, iyo nyandiko ikurikirana igabanya ibiganiro byubahirizwa: ikibazo gihinduka niba uwabikoze ashobora kuzuza ibisabwa na Amerika muburyo bw'icyitegererezo gihuye na gahunda.
Kuboneka Gukwirakwiza na OEM / ODM Gahunda
Ubuvuzi bwa Joytech burimo kwakira ibibazo by’abaguzi b’ibikoresho by’ubuvuzi bo muri Amerika, abatumiza mu mahanga, hamwe n’abafatanyabikorwa bashishikajwe n’uruhererekane rwa DBP Plus - harimo iterambere ry’ibirango bwite, gupakira ibicuruzwa, hamwe n’inkunga yo kwandikisha isoko.
Ibyerekeye Ubuvuzi bwa Joytech
Joytech Healthcare ni uruganda rukora ubuvuzi bwurugo n’ibikoresho byo gukurikirana ubuvuzi, kabuhariwe mu kugenzura umuvuduko wamaraso, therometero, pulse oximeter, nebulizers, pompe yamabere nibindi bicuruzwa byubuzima.
Turatanga OEM / ODM ibikoresho byubuvuzi ibisubizo kubirango byita ku buzima ku isi, abagabura, n’abafatanyabikorwa, byibanda ku kubahiriza amabwiriza, kwizerwa ku bicuruzwa, n’ubufatanye burambye.
Gusaba ibyitegererezo byo gusuzuma, ibyangombwa bisobanutse, cyangwa amagambo yatanzwe kuri seriveri ya DBP Plus, shikira ikipe yacu kuri sale14@sejoy.com - cyangwa reba FDA 510 (k) yuzuye umurongo wogukurikirana umuvuduko wamaraso kurubuga rwacu.
