Ukukhuseleka kwesixhobo segazi lezonyango kwi-FDA CE I-OSO
Iseti yokuqokelelwa kwegazi, ekwabizwa ngokuba yinxuwa yebhabhathane, sisixhobo sonyango esisetyenziselwa ukufumana iisampulu zegazi kuvavanyo okanye umnikelo. Yenzelwe ukunxibelelana netyhubhu ye-vacuum okanye isirinji yokuqokelela igazi. I-SET ihlala inementi emfutshane, ityhubhu eguqukayo, kwaye ngamanye amaxesha isixhobo sokhuseleko siyigubungele inaliti emva kokusetyenziswa. Iqhelekile isetyenziswa kwizicwangciso zeklinikhi ezinje ngezibhedlele, iilebhu, kunye namaziko okunika igazi. Inaliti yebhabhathane iluncedo ngakumbi xa ufikelela kwiithambo ekunzima ukufikelela kuyo, njengaleyo sezandla okanye ithambo elincinci ebantwaneni.
Iimpawu kunye neziBonelelo
CE
ISO13485
I-USA FDA 510K
En iso 13485: 2016 / AC: I-2016 Inkqubo yoLawulo lweMigangatho yoNyango lweeMfuno zoLawulo
En iso 14971: 2012 Izixhobo zonyango zezonyango-Ukusetyenziswa kolawulo lomngcipheko kwizixhobo zonyango
I-ISO 11135: 2014 Isixhobo seCografic South Axlene Oxide kunye nolawulo ngokubanzi
I-ISO 6009: 2016 Ukulahla inaliti yokufumana inaliti chonga ikhowudi yombala
ISO 7864: 2016 Ukulahla inaliti yenaliti
I-ISO 9626: 2016: I-2016 i-tuby yenqwaba yentsimbi ye-Inforle yokwenziwa kwezixhobo zonyango
Iqela leqela leqela leqela leQumrhu ngumboneleli ophambili weemveliso zezonyango kunye nezisombululo.
Ngaphezulu kweminyaka eli-10 yokhathalelo lwempilo, sinikezela ekukhetheni imveliso ebanzi, amaxabiso okhuphiswano, iinkonzo ezizodwa, kunye nokuhanjiswa okuthembekileyo. Sibe ngumthengisi weSebe lezeMpilo lase-Australia (i-AGDH) kunye neSebe leCalifornia kwiMpilo yoLuntu (i-CDPH). E China, sikwinqanaba phakathi kwababoneleli abaphambili bokufakwa, inaliti, ukufikelela, izixhobo zokubuyisela kwimeko yesiqhelo, i-hemodialysis, iimveliso ze-biopsy kunye neemveliso ze-biopsy kunye neemveliso ze-biopsy kunye neemveliso ze-biopsy kunye neemveliso ze-biopsy.
Ngowama-2023, sasingenise iimveliso zokuphumelela kubathengi kumazwe ali-120 +, kubandakanya i-USA, EU, Mpuma, nakumazantsi empuma yeAsia. Izenzo zethu zemihla ngemihla zibonisa ukuzahlulela kwethu kunye nokuphendula kwiimfuno zabathengi, kusenza iqabane elithembekileyo nelihlanganisiweyo lokuzikhethela.
Sifumene igama elihle phakathi kwabathengi ngenxa yenkonzo elungileyo kunye nexabiso lokhuphiswano.
A1: Sinamava ali-10 kule ntsimi, inkampani yethu ineqela lengcali kunye nemveliso yobungcali.
A2. Iimveliso zethu ezinomgangatho ophezulu kunye nexabiso lokhuphiswano.
I-A3.UI-10000PCS; Singathanda ukusebenzisana nawe, akukho zixhala malunga ne-moq, zisingezela ukuba zeziphi izinto ozifunayo.
I-A4.YES, i-LOPOORK yamkelwe.
I-A5: Ngokwesiqhelo sigcina uninzi lweemveliso esitokhweni, sinokuthumela iisampulu kwiisampuli ezi-5-10 zomsebenzi.
A6: Sithumela ngeFedEx.ups, DHL, EMS okanye ulwandle.
IInaliti yebhabhathaneyinguquIsixhobo sokuqokelela igaziidibanisa ukuphumla kokufumana kunye nokukhuseleka kweI-Butterfly inalitingokhuseleko olongezelelekileyo lwenaliti. Esi sixhobo sinobuchule sisetyenziselwa ukuqokelela iisampulu zegazi kwizigulana zovavanyo lwezonyango ezahlukeneyo kunye neenkqubo. Inaliti yebhabhathane ebuyiselweyo ixhotywe ngenkqubo yentwasahlobo evumela ukuba inaliti iphinde ibuyise kwindawo yokuhlala emva kokusetyenziswa, ukunciphisa umngcipheko wokwenzakala kwenzekileyo. Isixhobo siyingenelo ikakhulu kubasebenzi bezempilo abahlala bephethe iinkqubo zokuqokelela igazi, njengoko zinciphisa umngcipheko we-stick yentswelo ngengozi.
