Kubikwa ukuthi i-Haiyan Kangyuan Medical Instrument Co., Ltd. ithole ngempumelelo isitifiketi se-CE se-EU Medical Device Regulation 2017/745 (ebizwa ngokuthi "MDR") emikhiqizweni emibili ngenyanga edlule. Imikhiqizo i-PVC Laryngeal Mask Airways kanye ne-Latex Foley Catheters Yokusetshenziswa Okukodwa. Njengamanje, imikhiqizo eyi-12 ye-Kangyuan Medical isiphumelele isitifiketi se-MDR, esimi kanje:

[Endotracheal Tubes for Single Use];

[Ama-Catheter Amunca Oyinyumba Okusetshenziswa Kakodwa];

[Izifihla-moya Zomoya Zokusetshenziswa Kanye];

[AmaCannula Oxygen Wamakhala Okusetshenziswa Kanye];

[I-Guedel Airways for Single Use];

[I-Laryngeal Mask Airways];

[Imaski Yokubulala Izinzwa Zokusetshenziswa Kanye];

[Izihlungi Zokuphefumula Zokusetshenziswa Okukodwa];

[Iziyingi Zokuphefumula Zokusetshenziswa Okukodwa];

[Ama-Urinary Catheter for Use single (Foley)];

[Latex Foley Catheters for Single Use];

[PVC Laryngeal Mask Airways]

 

Isitifiketi se-EU MDR sibonisa ukuthi imikhiqizo ye-Kangyuan Medical ihlangabezana nezimfuneko zomthethonqubo wakamuva we-EU wedivayisi yezokwelapha 2017/745 futhi inezimo zakamuva zokufinyelela zemakethe ye-EU. Lokhu akukhona nje kuphela ukuqashelwa okuphezulu kwekhwalithi, ukuphepha nokusebenza ngempumelelo kwemikhiqizo yezokwelapha yase-Kangyuan, kodwa futhi kuwukubonakaliswa okubalulekile kwamandla enkampani ezobuchwepheshe kanye nokuncintisana kwemakethe. I-Kangyuan Medical izothatha leli thuba ukuthuthukisa imakethe yaseYurophu futhi inikeze izinsizakalo zezokwelapha ezisezingeni eliphezulu ezigulini eziningi emhlabeni jikelele.