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 kwazo.Ihlukaniswe ngo-Chinukubhaliswa kwemishini yezokwelapha yasekhaya kanye nokubhaliswa kwemishini yezokwelapha yaphesheya.Imishini yezokwelapha yaphesheya kwezilwandle, kungakhathaliseki ukuthi ikilasi I, ikilasi II noma isigaba III, kufanele isingathwe yi-Beijing State Food and Drug Administration: imishini yezokwelapha yesigaba I kanye nesigaba II kufanele isingathwe ukulawulwa kokudla nezidakamizwa kwesifundazwe noma kukamasipala, kanye nesigaba. Imishini yezokwelapha ye-III kufanele iphathwe yi-State Food and Drug Administration.Isitifiketi sokubhaliswa kwedivayisi yezokwelapha sibhekisela ekhadini le-ID elisemthethweni lemikhiqizo yensiza yezokwelapha.
Ngokwemithethonqubo yokwengamela nokuphathwa kwemishini yezokwelapha, izinyathelo zokuqondisa nokuphathwa kokukhiqizwa kwemishini yezokwelapha kanye nezinyathelo zokulawulwa kokubhaliswa kwemishini yezokwelapha ekhishwe Umbuso Wokudla Nezidakamizwa, imikhiqizo yemishini yezokwelapha ekhiqizwayo kanye/ noma okuthengiswa eShayina kuzohlangabezana 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 kanje:
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 |
