Isitifiketi sokubhaliswa kwedivayisi yezokwelapha yase-People's Republic of China
Ukubhaliswa kwemishini yezokwelapha kusho inqubo yokuhlola ngokuhlelekile ukuphepha nokusebenza kahle kwemishini yezokwelapha ezothengiswa futhi isetshenziswe ngokuhambisana nezinqubo zomthetho, ukuze kunqunywe ukuthi kuyavumelana yini nokudayiswa nokusetshenziswa kwayo. Ihlukaniswe ngo-Chinukubhaliswa kwemishini yezokwelapha yasekhaya kanye nokubhaliswa kwemishini yezokwelapha yaphesheya. Imishini yezokwelapha yaphesheya kwezilwandle, kungaba isigaba I, isigaba II noma isigaba III, kufanele isingathwe Ukuphathwa Kwezokudla Nezidakamizwa Zesifunda SaseBeijing: Imishini yezokwelapha yesigaba I kanye nesigaba II kufanele isingathwe ukulawulwa kokudla nezidakamizwa kwesifundazwe noma kukamasipala, kanye nemishini yezokwelapha yesigaba III kufanele isingathwe Ukulawulwa Kwezokudla Nezidakamizwa Zombuso. Isitifiketi sokubhaliswa kwemishini yezokwelapha sisho ikhadi likamazisi elisemthethweni lemikhiqizo yensiza yezokwelapha.
Ngokwemithethonqubo yokuqondisa nokuphathwa kwemishini yezokwelapha, izinyathelo zokuqondisa nokuphathwa kokukhiqizwa kwemishini yezokwelapha kanye nezinyathelo zokulawulwa kokubhaliswa kwemishini yezokwelapha ekhishwe Umbuso Wokudla kanye nokuphathwa kwezidakamizwa, imikhiqizo yensiza yezokwelapha ekhiqizwe kanye/noma ethengiswa eShayina izohlangabezana nezidingo ezihambisanayo zokulawula. Lezi zidingo zihlanganisa:
1) Umkhiqizi wemishini yezokwelapha uthola ilayisensi yokukhiqiza;
2) Imikhiqizo yemishini yezokwelapha ithole isitifiketi sokubhaliswa.
I-Foosin isivele ithola Ukubhaliswa Kwezokwelapha e-China kusukela ngo-2006 inguqulo yakamuva kanjena:
Inombolo yesitifiketi sokubhalisa: lxzz 20152020252
| Igama lobhalisile | Foosin medical materials Co., Ltd |
| Indawo yokubhalisa | 20, Xingshan Road, Weihai Torch Hi-tech Science Park |
| Ikheli lokukhiqiza | 20, Xingshan Road, Weihai Torch Hi-tech Science Park |
| Igama le-ejenti | |
| Indawo yokuhlala yomenzeli | |
| Igama lomkhiqizo | Umthungo wokuhlinza ongamunceki |
| Imodeli kanye nokucaciswa | Bheka isijobelelo esinamathiselwe |
| Isakhiwo kanye nokwakheka | Umkhiqizo uqukethe inaliti ye-suture kanye ne-suture yokuhlinzwa engamuncwa. |
| Ububanzi besicelo | Ilungele ukuthunga izicubu zomuntu. |
| indawo ebiyelwe | Izidingo zobuchwepheshe bomkhiqizo: lxzz 20152020252 |
| Okunye okuqukethwe | |
| amazwi | Isitifiketi sokuqala sokubhaliswa kwedivayisi yezokwelapha Inombolo: lxzz 20152650252 |
| Kugunyazwe ngabakwa-: Shandong Provincial Drug Administration |
| Usuku lokugunyaza: Mashi 25, 2020 |
| Isebenza kuze kube: Mashi 24, 2025 |
| (umnyango wokugunyaza) |
Okunamathiselwe:
| Pigama lomzila | Niloni | Pi-olypropylene | Pi-olyester | Silk |
| USP | 10-(0#-2#） | 10-(0#-2#） | 8-(0#-2#） | 8-(0#-5#） |
| Ubude be-Suture | 30cm-299cm | 45cm-299cm | 45cm-299cm | 30cm-299cm |
| Ububanzi benaliti × Ubude beChord (0.1mm×mm） | (1.5-15)×(4.5-55） | (2-15)×(6-55） | (2-15)×(6-55） | (1.5-15)×(6-65） |
| Ijika | 1/2, 3/8, 1/4, 5/8 | 1/2, 3/8, 1/4, 5/8 | 1/2, 3/8, 1/4, 5/8 | 0,1/2, 3/8, 1/4, 5/8 |
| Nuhlobo lwe-edle | Umzimba oyindilinga, ukusika, i-spatula | Umzimba oyindilinga, ukusika, ukusika kwe-taper | Umzimba oyindilinga, ukusika | Umzimba oyindilinga, ukusika, ukusika kwe-taper |
| Nubuningi be-edle | 0-8 | 0-8 | 0-8 | 0-16 |
