I-CE FDA eLahlayo yoKhuseleko lwe-insulin yesirinji enenaliti
Ividiyo yeMveliso
Inkcazo
I-1.Imveliso yenziwe ngezinto zepolymer zonyango.
2.Inaliti igxininiswe kwi-nozzle, incam yenaliti ebukhali kakhulu, ukulinganisa okucacileyo kunye nokuchanekileyo, kwaye inokugqiba ngokuchanekileyo idosi.
3.Inaliti eNyiweyo, Akukho Sithuba sifileyo, Akukho nkunkuma
I-4.I-barrel ecacileyo ngokwaneleyo ivumela ukulinganisa okulula komthamo oqulethwe kwisirinji kunye nokufumanisa i-bubble yomoya.
5. Isikali esithweswe isidanga kwi-barrel kulula ukuyifunda. Isidanga siprintwa nge-inki engacimiyo.
I-6.I-plunger ingena ngaphakathi kwi-barrel kakuhle kakhulu ukuvumela ukuhamba kwamahhala kunye nokugudileyo.
Uphawu
Isirinji ye-insulin elahlayo ngobukhulu obahlukeneyo
UMBONO
Inkcazo: 0.3ml, 0.5ml kunye ne-1ml (U-100 okanye U-40)
Material: Yenziwe kwibakala lezonyango pp
Isiqinisekiso: CE, ISO13485 isatifikethi
Iphakheji: Iphakheji ye-blister
Inaliti: Inaliti esisigxina
Isikali: Iimpawu ezinkulu ezicacileyo zeyunithi
Ayinyumba:Ngerhasi ye-EO
Ubungakanani: 0.3ml, 0.5ml kunye ne-1ml.
Inaliti: 29G, 30G kunye ne-31G.
Inkcazo
| Izinto eziphathekayo | I-Cap & Barel & Plunger: Ibakala lezonyango PP |
| Inaliti: Intsimbi engatyiwayo | |
| I-Piston: I-Latex okanye iLatex yaMahala | |
| Umthamo | 0.3ml, 0.5ml ,1ml |
| Isicelo | Ezonyango |
| Uphawu | Iyalahlwa |
| Isiqinisekiso | CE, ISO |
| Inaliti | ngenaliti esisigxina okanye inaliti eyahluliweyo |
| Umbhobho | I-nozzel ephakathi |
| Umbala wePlunger | Transparent , white , colored |
| Umphanda | Okusekuhleni okuphezulu |
| Iphakheji | Iphakheji yomntu ngamnye:I-Blister/PE ukupakisha |
| Iphakheji yesibini: Ibhokisi | |
| Iphakheji yangaphandle: Ibhokisi | |
| Unyumba | intsholongwane ngerhasi ye-EO, engeyotyhefu, engeyiyo ipyrogen |
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.
