Ukuqokelelwa kweGazi kwiSixhobo soNyango Seta i-FDA CE ISO
Iseti yokuqokelela igazi, eyaziwa ngokuba yinaliti yebhabhathane, sisixhobo sonyango esisetyenziselwa ukufumana iisampulu zegazi lokuvavanya okanye ukunikela. Yenzelwe ukudibanisa ityhubhu yevacuum okanye isirinji yokuqokelela igazi. Isethi idla ngokuba nenaliti emfutshane, iityhubhu eguquguqukayo, kwaye ngamanye amaxesha isixhobo sokhuseleko sokuvala inaliti emva kokusetyenziswa. Isetyenziswa ngokuqhelekileyo kwizicwangciso zeklinikhi ezifana nezibhedlele, iilabhoratri, kunye namaziko okunikela ngegazi. Inaliti yebhabhathane iluncedo kakhulu xa ufikelela kwimithambo ekunzima ukufikelela kuyo, njengaleyo isezandleni okanye imithambo emincinci ebantwaneni.
Iimpawu kunye neeNzuzo
CE
ISO13485
I-USA FDA 510K
I-EN ISO 13485: 2016/AC:2016 Inkqubo yolawulo lwezixhobo zonyango kwiimfuno zolawulo
I-EN ISO 14971 : Izixhobo zonyango ze-2012-Ukusetyenziswa kolawulo lomngcipheko kwizixhobo zonyango
I-ISO 11135: 2014 Isixhobo soNyango Ukwenziwa inzala kwe-ethylene oxide Ukuqinisekiswa kunye nolawulo jikelele
I-ISO 6009: 2016 Iinaliti ezilahlwayo zenaliti engasebenziyo Chonga ikhowudi yombala
I-ISO 7864: 2016 Iinaliti ezilahliweyo zenaliti
I-ISO 9626: I-2016 Iityhubhu zeenaliti zensimbi ezingenasici zokwenza izixhobo zonyango
I-SHANGHAI TEAMSTAND CORPORATION ngumboneleli okhokelayo weemveliso zonyango kunye nezisombululo.
Ngaphezulu kweminyaka eyi-10 yamava obonelelo lwezempilo, sinikezela ngokukhethwa kwemveliso ebanzi, amaxabiso akhuphisanayo, iinkonzo ezikhethekileyo ze-OEM, kunye nokuhanjiswa kwexesha elithembekileyo. Siye saba ngumthengisi weSebe lezeMpilo lase-Australia (AGDH) kunye neSebe laseCalifornia lezeMpilo kaRhulumente (CDPH). E-China, sibeka phakathi kwababoneleli abaphezulu be-Infusion, i-Injection, i-Vascular Access, i-Rehabilitation Equipment, i-Hemodialysis, i-Biopsy Needle kunye neemveliso zeParacentesis.
Ngo-2023, sasisele sihambise ngempumelelo iimveliso kubathengi kumazwe ali-120+, kuquka i-USA, i-EU, uMbindi Mpuma, kunye noMzantsi-mpuma Asia. Izenzo zethu zemihla ngemihla zibonisa ukuzinikela kwethu kunye nokuphendula kwiimfuno zabathengi, kusenza sibe liqabane elithembekileyo nelidibeneyo loshishino lokuzikhethela.
Sifumene igama elihle phakathi kwabo bonke aba bathengi ngenkonzo elungileyo kunye nexabiso elikhuphisanayo.
A1: Sineminyaka eyi-10 yamava kule ndawo, inkampani yethu ineqela lobuchwephesha kunye nomgca wokuvelisa.
A2. Iimveliso zethu ezikumgangatho ophezulu kunye nexabiso elikhuphisanayo.
I-A3.Ngesiqhelo yi-10000pcs; singathanda ukusebenzisana nawe, akukho maxhala malunga ne-MOQ, sithumele nje ukuba zeziphi izinto ozifunayo.
A4.Ewe, i-LOGU ngokwezifiso zamkelwe.
A5: Ngokuqhelekileyo sigcina uninzi lweemveliso kwi-stock, sinokuthumela iisampuli ngaphandle kwe-5-10workdays.
I-A6: Sithumela nge-FEDEX.UPS, DHL, EMS okanye uLwandle.
IInaliti yeButterfly eRetractablengumguquliisixhobo sokuqokelela igaziedibanisa ukusetyenziswa lula kunye nokhuseleko ainaliti butterflykunye nokhuseleko olongezelelweyo lwenaliti ebuyiselwayo. Esi sixhobo sitsha sisetyenziselwa ukuqokelela iisampulu zegazi kwizigulana kwiimvavanyo ezahlukeneyo zonyango kunye neenkqubo. Inaliti yebhabhathane ehoxisayo ixhotyiswe ngesixhobo sentwasahlobo esivumela inaliti ukuba irhoxe kwindlu emva kokusetyenziswa, ukunciphisa umngcipheko wokulimala kweenaliti. Isixhobo siluncedo kakhulu kubasebenzi bezempilo abahlala bephatha iinkqubo zokuqokelela igazi, njengoko kunciphisa umngcipheko weenaliti zengozi.
