Isethi Yokuqoqwa Kwegazi Lokuphepha Kwedivayisi Yezokwelapha I-FDA CE ISO
Isethi yokuqoqwa kwegazi, eyaziwa nangokuthi inaliti yebhabhathane, iyithuluzi lezokwelapha elisetshenziselwa ukuthola amasampula egazi ukuze lihlolwe noma linikelwe. Lenzelwe ukuxhuma epayipini le-vacuum noma kwisirinji ukuze kuqoqwe igazi. Isethi ivame ukuba nenaliti emfushane, ipayipi eliguquguqukayo, futhi ngezinye izikhathi ithuluzi lokuphepha lokumboza inaliti ngemva kokusetshenziswa. Ivame ukusetshenziswa ezindaweni zemitholampilo njengezibhedlela, amalabhorethri, kanye nezikhungo zokunikela ngegazi. Inaliti yebhabhathane iwusizo kakhulu lapho kufinyelela imithambo enzima ukuyifinyelela, njengaleyo esezandleni noma imithambo emincane ezinganeni.
Izici kanye nezinzuzo
CE
I-ISO13485
I-USA FDA 510K
I-EN ISO 13485: 2016/AC: 2016 Uhlelo lokuphatha ikhwalithi yemishini yezokwelapha lwezidingo zomthetho
I-EN ISO 14971: Amadivayisi ezokwelapha ka-2012 - Ukusetshenziswa kokuphathwa kwezingozi kumadivayisi ezokwelapha
I-ISO 11135:2014 Idivayisi yezokwelapha Ukuhlanza i-ethylene oxide Ukuqinisekiswa nokulawulwa okujwayelekile
I-ISO 6009:2016 Izinaliti zomjovo ezilahlwayo ezingenamagciwane Khomba ikhodi yombala
I-ISO 7864:2016 Izinaliti zomjovo ezilahlwayo ezingenamagciwane
ISO 9626:2016 Amashubhu enaliti yensimbi engagqwali yokwenziwa kwamadivayisi ezokwelapha
I-SHANGHAI TEAMSTAND CORPORATION ingumhlinzeki ohamba phambili wemikhiqizo yezokwelapha nezixazululo.
Njengoba sineminyaka engaphezu kwe-10 yesipiliyoni sokuhlinzekwa kwezempilo, sinikeza ukukhetha okubanzi kwemikhiqizo, amanani ancintisanayo, izinsizakalo ze-OEM ezivelele, kanye nokulethwa okuthembekile ngesikhathi. Besilokhu sihlinzeka ngoMnyango Wezempilo Kahulumeni wase-Australia (AGDH) kanye noMnyango Wezempilo Yomphakathi waseCalifornia (CDPH). EShayina, sibalwa phakathi kwabahlinzeki abaphezulu be-Infusion, Injection, Vascular Access, Rehabilitation Equipment, Hemodialysis, Biopsy Needle kanye ne-Paracentesis products.
Ngo-2023, sase siphumelele ukuletha imikhiqizo kumakhasimende emazweni angaphezu kuka-120, okuhlanganisa i-USA, i-EU, i-Middle East, kanye ne-Southeast Asia. Izenzo zethu zansuku zonke zibonisa ukuzinikela kwethu kanye nokusabela ezidingweni zamakhasimende, okusenza sibe ngumlingani webhizinisi othembekile nohlanganisiwe esimthandayo.
Sithole idumela elihle phakathi kwala makhasimende ngenxa yesevisi enhle kanye nentengo encintisanayo.
A1: Sinesipiliyoni seminyaka eyi-10 kulo mkhakha, Inkampani yethu ineqembu lochwepheshe kanye nomugqa wokukhiqiza ochwepheshe.
A2. Imikhiqizo yethu enekhwalithi ephezulu kanye nentengo yokuncintisana.
A3. Ngokuvamile ingama-pcs ayi-10000; singathanda ukubambisana nawe, ungakhathazeki nge-MOQ, vele usithumelele izinto zakho ofuna ukuzi-oda.
A4.Yebo, ukwenziwa ngokwezifiso kwe-LOGO kuyamukelwa.
A5: Ngokuvamile sigcina iningi lemikhiqizo esitokweni, singathumela amasampula ezinsukwini zokusebenza ezi-5-10.
A6: Sithumela nge-FEDEX.UPS, DHL, EMS noma uLwandle.
IInaliti Yebhabhathane Ehoxiswayoungumvukeliidivayisi yokuqoqa igaziokuhlanganisa ukulula kokusetshenziswa kanye nokuphepha kwe-inaliti yebhabhathanengokuvikelwa okwengeziwe kwenaliti ehoxiswayo. Le divayisi entsha isetshenziselwa ukuqoqa amasampula egazi ezigulini ukuze kuhlolwe futhi kusetshenziswe izindlela ezahlukene zezokwelapha. Inaliti yebhabhathane ehoxiswayo ifakwe indlela yokuvula evumela inaliti ukuthi ihoxiswe endlini ngemva kokusebenzisa, okunciphisa ingozi yokulimala kwenaliti. Le divayisi iwusizo kakhulu kochwepheshe bezempilo abavame ukuphatha izinqubo zokuqoqa igazi, njengoba inciphisa ingozi yezinti zenaliti ezingalindelekile.













