I-CE FDA eLahlayo yoKhuseleko lwe-insulin yesirinji enenaliti

Inkcazelo emfutshane:

Isirinji ye-insulin yokhuseleko uyilo olutsha

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

Thumela i-imeyile kuthi

Iinkcukacha zeMveliso

Iithegi zeMveliso

Ividiyo yeMveliso

isirinji ye-insulin yobukhulu obahlukeneyo

Inkcazo yemveliso yoKhuseleko lwesirinji ye-insulin

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.

FUMANA ICACA NGOKU

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

Ukucaciswa kweSirinji ye-insulin yoKhuseleko

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

Ulawulo:

ISO13485

I-USA FDA 510K

Umgangatho:

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

Iprofayile yeNkampani yeTeamstand

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