Kubikwa ukuthi uHaiyan Kangyuan Medical Incense Co, Ltd. Uthole ngempumelelo isitifiketi se-CE se-EU Medical Regulation 2017/745 (Kubhekiselwa ku "MDR") emikhiqizweni emibili ngenyanga edlule. Imikhiqizo yi-PVC laryngeal mask airways nama-latex foley Catheters ukuze asetshenziswe okukodwa. Njengamanje, imikhiqizo eyi-12 yezokwelapha yaseKangyuan idlulise isitifiketi se-MDR, okulandelayo:

[Ama-cathereters ama-stile sucrent for single sebenzisa];

[Ama-oxygen we-nasal oksigen wokusetshenziswa okukodwa];

[I-Guerel Airways yokusetshenziswa okukodwa];

[Ama-Laryngeal Mask Airways];

[Ama-anesthesia masks wokusetshenziswa okukodwa];

[Ukuphefumula izihlungi zokusebenzisa okukodwa];

[Amasekethe aphefumulayo wokusebenzisa okukodwa];

[Amakhekhe ama-Urinary wokusebenzisa okukodwa (Foley)];

[PVC laryngeal mask airways]

 

Isitifiketi se-EU MDR sibonisa ukuthi imikhiqizo yezokwelapha yaseKangyuan ihlangabezana nezidingo zemithetho yedivayisi ye-EU yezokwelapha yakamuva ye-EU Medical Regulation 2017/745 futhi ibe nemibandela yokufinyelela yakamuva yeMakethe ye-EU. Lokhu akuyona nje ukuqashelwa okuphezulu kwekhwalithi, ukuphepha kanye nokusebenza kahle kwemikhiqizo yezokwelapha yaseKangyuan, kepha futhi nokubonakaliswa okubalulekile kwamandla ezobuchwepheshe enkampanini kanye nokuncintisana kwemakethe. I-Kangyuan Medical izothatha leli thuba ukuthuthukisa imakethe yaseYurophu futhi inikeze izinsizakalo zezokwelapha ezisezingeni eliphakeme ezigulini ezengeziwe emhlabeni jikelele.