Biravugwa ko Haiyan Kangyuan Medical Instrument Co., Ltd. yabonye neza icyemezo cya CE cy’amabwiriza y’ubuvuzi bw’ibihugu by’Uburayi 2017/745 (bita "MDR") mu bicuruzwa bibiri mu kwezi gushize. Ibicuruzwa ni PVC Laryngeal Mask Airways na Latex Foley Catheters yo Gukoresha Rimwe. Kugeza ubu, ibicuruzwa 12 byubuvuzi bwa Kangyuan byatsinze icyemezo cya MDR, aribyo bikurikira:

[Endotracheal Tubes yo Gukoresha Rimwe];

[Sterile Suction Catheters yo Gukoresha Rimwe];

[Masike ya Oxygene yo gukoresha rimwe];

[Urumogi rwa Oxygene yo mu mazuru yo gukoresha rimwe];

[Guedel Airways yo Gukoresha Rimwe];

[Laryngeal Mask Airways];

[Masike ya Anesthesia yo Gukoresha Rimwe];

[Guhumeka Akayunguruzo ko Gukoresha Rimwe];

[Guhumeka Inzira yo Gukoresha Rimwe];

[Catheters yinkari zikoreshwa rimwe (Foley)];

[Latex Foley Catheters yo Gukoresha Rimwe];

[PVC Laryngeal Mask Airways]

 

Icyemezo cya MDR cy’ubumwe bw’ibihugu by’Uburayi cyerekana ko ibicuruzwa by’ubuvuzi bya Kangyuan byujuje ibisabwa n’amabwiriza ajyanye n’ibikoresho by’ubuvuzi bya EU 2017/745 kandi bifite uburyo bugezweho bwo kugera ku isoko ry’Uburayi. Ntabwo ari ukumenyekanisha gusa ubuziranenge, umutekano n’ingirakamaro ku bicuruzwa by’ubuvuzi bya Kangyuan, ahubwo ni ikimenyetso cyerekana imbaraga za tekinike y’isosiyete ndetse no guhangana ku isoko. Ubuvuzi bwa Kangyuan buzaboneraho umwanya wo kurushaho kwagura isoko ry’iburayi no gutanga serivisi nziza z’ubuvuzi ku barwayi benshi ku isi.