Inaliti ye-Hypodermic Engalahlwayo Engasetshenziswa Kanye
Izici Zomkhiqizo
| Ukusetshenziswa okuhlosiwe | Inaliti ye-hypodermic engenamagciwane yokusetshenziswa kanye yenzelwe ukusetshenziswa namasirinji namadivayisi okujova ngenhloso evamile yokujova/ukufutha uketshezi. |
| Isakhiwo kanye nomanyolo | Ishubhu yenaliti, Ihabhu, Isivalo Esivikelayo. |
| Izinto Eziyinhloko | I-SUS304, i-PP |
| Isikhathi sokuphelelwa yisikhathi | Iminyaka emi-5 |
| Isitifiketi kanye nokuqinisekiswa kwekhwalithi | Ukuhlukaniswa okungu-510K: Ⅱ I-MDR (Isigaba se-CE: IIa) |
Amapharamitha Omkhiqizo
| Imininingwane | I-Luer slip kanye ne-Luer lock |
| Usayizi Wenaliti | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G |
Isingeniso Somkhiqizo
Sethula izinaliti zethu ze-Sterile Disposable (hypodermic), ithuluzi elithembekile nelibalulekile kochwepheshe bezokwelapha. Lezi zinaliti ze-hypodermic zenzelwe ukusetshenziswa kalula, zikhulisa ukuphepha kwesiguli futhi ziqinisekise ukuthi inqubo ngayinye yenziwa ngokunemba nangokucophelela.
Izinaliti ze-hypodermic zitholakala ngobukhulu obuhlukahlukene, okuhlanganisa i-18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G kanye ne-34G ukuze kuhlangatshezwane nezidingo ezahlukene zezokwelapha. Njengoba zinokuxhumana kwe-Luer Slip kanye ne-Luer Lock, ziyahambisana nezinhlobo eziningi zamasirinji kanye namadivayisi okujova, okwenza zifaneleke ukujova uketshezi kanye nokufuthwa kwento ethile.
Ngokugxila kakhulu ekhwalithini nasekuphepheni, lezi zinalithi zenziwe ngezinto ezingezona ezinobuthi futhi zihlanjululwe kahle ukuze kususwe ukungcola. Ukwakheka kwazo kokusetshenziswa kanye kuqinisekisa ukuthi inalithi ngayinye isetshenziswa kanye kuphela, okunciphisa kakhulu ingozi yokutheleleka kanye nokungcola.
Imikhiqizo yethu ihlangabezana nezindinganiso eziphakeme zemboni, ivunyelwe yi-FDA 510(k), futhi ikhiqizwa ngokuhambisana nezimfuneko ze-ISO 13485. Lokhu kubonisa ukuzibophezela kwethu ekulawuleni ikhwalithi okuqinile kuyo yonke inqubo yokukhiqiza, ukuqinisekisa ukuthi wonke amakhasimende athola imikhiqizo yekhwalithi ephezulu kakhulu.
Ngaphezu kwalokho, izinaliti zethu ze-hypodermic ezingenamagciwane zihlukaniswa njengeSigaba II ngaphansi komthethonqubo we-FDA 510(k) futhi zihambisana ne-EU MDR (CE Class IIa). Lokhu kuqinisekisa ukuthembeka kwazo nokuphepha ekusetshenzisweni kwemitholampilo, okunikeza ochwepheshe bezempilo ukuzethemba okugcwele.
Ngamafuphi, izinaliti ze-KDL ezingasebenzi kahle ezisebenzisa i-hypodermic ziyimishini ebalulekile yezokwelapha ngenxa yokungazali kwazo, izinto ezingezona ezinobuthi, kanye nokuhambisana ngokugcwele nezindinganiso zemboni yamazwe ngamazwe. Ngemikhiqizo yethu, ochwepheshe bezempilo bangenza izinqubo ngokuqiniseka, bethembele kumadivayisi aphephile, athembekile, futhi anobungane asebenzisa kahle abeka phambili inhlalakahle yesiguli.












