Haiyan Kangyuan Medical Instrument Co., Ltd. ya samu nasarar samun Dokar Na'urar Lafiya ta Tarayyar Turai 2017/745 (wanda ake magana da ita a matsayin "MDR") takardar shedar CE a ranar 19 ga Yuli, 2023, lambar takardar shaidar 6122159CE01, iyakokin takaddun shaida shine Catheters na Urinary don Amfani guda ɗaya. Foley), Musamman ya haɗa da catheter silicone foley catheter 2, 3 hanyar silicone foley catheter, 2 hanyar silicone foley catheter tare da tip tiemann da 3 hanyar silicone foley catheter tare da tip coude. A halin yanzu, Kangyuan Medical ya wuce samfuran MDR:
Endotracheal Tubes don amfani guda ɗaya;
Bakararre tsotsa catheters don amfani guda ɗaya;
Masks na Oxygen don Amfani guda ɗaya;
Cannulas Oxygen Nasal don Amfani guda ɗaya;
Guedel Airways don Amfani guda ɗaya;
Laryngeal Mask Airways;
Masks na Anesthesia don Amfani guda ɗaya;
Matatun Numfashi don Amfani Guda ɗaya;
Hawan numfashi don amfani guda ɗaya;
Catheters na fitsari don amfani guda ɗaya (Foley).
Takaddun shaida na MDR na EU ya nuna cewa Kangyuan Medical kayayyakin sun cika buƙatun sabuwar ƙa'idar na'urar likitancin EU ta 2017/745, suna da sabbin yanayin samun damar kasuwar EU, kuma ana iya ci gaba da sayar da su bisa doka a kasuwannin ketare masu dacewa, suna kafa tushe mai ƙarfi don kara shiga kasuwannin Turai da kuma inganta tsarin tsarin kasa da kasa.
Lokacin aikawa: Yuli-26-2023