Haiyan Kangyuan Medical Instrument Co., Ltd. yabonye neza Amabwiriza y’ibikoresho by’ubuvuzi by’ubumwe bw’ibihugu by’i Burayi 2017/745 (byitwa “MDR”) CE ku ya 19 Nyakanga 2023, icyemezo nomero 6122159CE01, impamyabumenyi ni Urwego Catheters yo Gukoresha Rimwe ( Foley), Byumwihariko harimo inzira 2 silicone foley catheter, inzira 3 ya silicone foley catheter, inzira 2 ya silicone foley catheter hamwe na tiemann hamwe ninzira 3 silicone foley catheter hamwe na coude tip.Kugeza ubu, Ubuvuzi bwa Kangyuan bwatsinze ibicuruzwa bya MDR:

Imiyoboro ya Endotracheal yo gukoresha imwe ；

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;

Anesthesia Mask yo Gukoresha Rimwe;

Guhumeka Akayunguruzo ko Gukoresha Rimwe;

Guhumeka Inzira yo Gukoresha Rimwe;

Catheters yinkari zo gukoresha imwe (Foley).

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 by’ubumwe bw’ibihugu by’Uburayi 2017/745, bifite uburyo bugezweho bwo kubona isoko ry’ubumwe bw’ibihugu by’Uburayi, kandi birashobora gukomeza kugurishwa mu buryo bwemewe n’amasoko ajyanye n’amahanga, bigashyiraho urufatiro rukomeye kuri kurushaho kwinjira ku isoko ry’iburayi no guteza imbere inzira mpuzamahanga.