I-Ce/FDA Igunyazwe Isirinji Sokuphepha Esihosheka Sezokwelapha Ukuze Kuvikelwe Umhlengikazi Neziguli
Imijovo yokuphepha ehosheka ngokuzenzakalela ivame ukusetshenziswa ezibhedlela, emitholampilo, nakwezinye izilungiselelo zokunakekelwa kwempilo ezinhlobonhlobo zezinqubo zezokwelapha, okuhlanganisa ukunikeza imithi, ukudonsa igazi, nokuletha imijovo, konke kuyilapho kunciphisa ingozi yokulimala kwenaliti kanye nezifo.
Amasirinji okuphepha ahosheka ngokuzenzakalelayo angamadivayisi ezokwelapha ahlakaniphile aklanyelwe ukuthuthukisa ukuphepha ngesikhathi sokujova futhi avikele kokubili ochwepheshe bezempilo neziguli ekulimaleni kwenaliti.
| Uhlobo lwesirinji | Isiringi Sokuphepha Esilahlwayo Sezokwelapha |
| Ivolumu | 1mL, 2mL(2.5mL), 3mL, 5mL, 10mL, 20mL, 30mL, 50mL, 60mL. |
| I-Ethylene Oxide Sterilization | Yebo |
| Isitifiketi | CE, FDA, ISO13485 |
| Isampula | Mahhala (7-10days) |
| Iphakheji | I-blister noma i-PE packing |
| Izinsuku zokulethwa | Izinsuku ezingu-15-20 |
| Umbhobho | I-nozzel ephakathi noma i-side nozzle |
| Uhlobo lwe-Plunger | Okusobala , okumhlophe , okuluhlaza okwesibhakabhaka, okuphuzi |
| Umgqomo | Okusobala |
| OEM/ODM | Kuyamukeleka |
Izici:
1. Ukuhoxiswa Kwenaliti Okuzenzakalelayo: Isici esiyinhloko ukuhoxiswa kwenaliti okuzenzakalelayo emgqonyeni wesirinji ngemva kokuqedwa komjovo.
2. Idizayini Elungele Umsebenzisi: Imijovo ehosha ngokuzenzakalelayo iklanyelwe ukuba isebenziseke kalula futhi ibe nenembile.
3.Ukusebenza Kwesandla Esisodwa:Lesi sici sinika amandla imijovo elula nephumelelayo, ikakhulukazi kuzilungiselelo zokunakekelwa kwezempilo okumatasa.
4. Ukuvimbela Ukulimala Kwenaliti: Lokhu kubaluleke kakhulu kubasebenzi bezempilo abavame ukujova futhi abasengozini enkulu yokulimala okunjalo.
CE
ISO13485
I-USA FDA 510K
I-TS EN ISO 13485: 2016/AC:2016 Uhlelo lokuphatha ikhwalithi yempahla yezokwelapha ngezidingo zokulawula
I-TS EN ISO 14971 Amadivayisi wezokwelapha ka-2012 - Ukusetshenziswa kokulawulwa kobungozi emishinini yezokwelapha
I-ISO 11135:2014 Idivaysi yezokwelapha Ukuvalwa inzalo kwe-ethylene oxide Ukuqinisekisa nokulawula okujwayelekile
I-ISO 6009:2016 Izinaliti zomjovo oyinyumba ezilahlwayo Thola ikhodi yombala
I-ISO 7864: 2016 Izinaliti zomjovo oyinyumba ezilahlwayo
I-ISO 9626:2016 Amashubhu enaliti ensimbi engagqwali okwakhiwa kwemishini yezokwelapha
I-SHANGHAI TEAMSTAND CORPORATION ingumhlinzeki oholayo wemikhiqizo yezokwelapha nezisombululo.
Ngaphezulu kweminyaka eyi-10 yokuhlangenwe nakho kokuhlinzekwa kokunakekelwa kwezempilo, sinikezela ngokukhethwa komkhiqizo okubanzi, amanani ancintisanayo, izinsizakalo ze-OEM ezihlukile, kanye nokulethwa okuthembekile ngesikhathi. Sibe ngabahlinzeki boMnyango Wezempilo Kahulumeni Wase-Australia (AGDH) kanye Nomnyango Wezempilo Yomphakathi wase-California (CDPH). E-China, sikleliswe phakathi kwabahlinzeki abaphezulu boMjovo, Umjovo, Ukufinyelela Kwemithambo, Izisetshenziswa Zokuvuselela, I-Hemodialysis, Inalithi Ye-Biopsy kanye nemikhiqizo ye-Paracentesis.
Ngo-2023, sase silethe ngempumelelo imikhiqizo kumakhasimende emazweni angu-120+, okuhlanganisa i-USA, EU, Middle East, kanye neSoutheast Asia. Izenzo zethu zansuku zonke zibonisa ukuzinikela kwethu kanye nokusabela kwethu ezidingweni zamakhasimende, kusenza sibe umlingani webhizinisi othembekile nodidiyelwe okhethwayo.
Sizuze idumela elihle phakathi kwawo wonke lawa makhasimende ngenkonzo enhle kanye nentengo yokuncintisana.
I-A1: Sinesipiliyoni seminyaka eyi-10 kulo mkhakha, Inkampani yethu ineqembu lochwepheshe kanye nomugqa wokukhiqiza oqeqeshiwe.
A2. Imikhiqizo yethu enekhwalithi ephezulu kanye nentengo yokuncintisana.
I-A3.Ngokujwayelekile i-10000pcs; singathanda ukubambisana nawe, akukho ukukhathazeka mayelana ne-MOQ, vele usithumelele ukuthi yiziphi izinto ofuna uku-oda.
A4.Yebo, ukwenza ngokwezifiso Ilogo kwamukelwe.
I-A5: Imvamisa sigcina iningi lemikhiqizo esitokweni, singathumela amasampula ngezinsuku zokusebenza ezingama-5-10.
I-A6: Sithumela nge-FEDEX.UPS, DHL, EMS noma uLwandle.
Iyini isirinji yokuphepha-TEAMSTAND
Izingozi zezokwelapha ezihlobene nezinaliti ezivamile azikho ngaphansi kwalezo ezihlotshaniswa namasirinji. Izinkampani zasekhaya nakwamanye amazwe ziye zafaka ngamandla umjovo ophephile ocwaningweni nasekuthuthukisweni kwemishini yezokwelapha, kodwa kunemishini eminingi yomjovo ephephile ekhona emakethe: enye iyizindleko eziphakeme zokukhiqiza, enye iyinqubo yokukhiqiza eyinkimbinkimbi; okwesithathu yikhwalithi yokukhiqiza okunzima ukuyiqinisekisa; okwesine, izisebenzi zezokwelapha eziyisicefe; ezinhlanu kunzima ukuqinisekisa umsebenzi ephephile. Ngaphezu kwalokho, inaliti yomjovo iqine kakhulu ngenxa yezizathu ezibonakalayo ngesikhathi sokuhlehla. [0004] Ngakho-ke, ukuthuthukiswa kwenaliti yomjovo wokuphepha ohoxisayo olahlwayo kunokubaluleka okukhulu futhi kwesikhathi eside ukuthuthukisa inaliti yomjovo ophephile olahlwayo. Ngakho-ke, isirinji ephephile ibaluleke kakhulu. Singakuhlinzeka ngezinkonzo ezisezingeni eliphezulu nezisezingeni eliphezuluimijovo ephephileinaliti inaliti yokuphephaIsipetu se-RetractalbeKhubaza ngokuzenzakalela isipetu
