I-Haiyan Kangyuan Medical Instrument Co., Ltd. ithole ngempumelelo isitifiketi se-European Union Medical Device Regulation 2017/745 (esibizwa ngokuthi “MDR”) CE isitifiketi ngoJulayi 19, 2023, inombolo yesitifiketi 6122159CE01, ububanzi besitifiketi ngama-Urinary Catheters for Use Single ( Foley), Ihlanganisa ngokukhethekile i-silicone foley catheter yezindlela ezi-2, i-silicone ye-foley catheter enezindlela ezingu-3, ​​i-silicone ye-foley catheter enezindlela ezimbili enethiphu ye-tiemann kanye ne-3 way silicone foley catheter ene-coude tip. Njengamanje, i-Kangyuan Medical isidlulile imikhiqizo ye-MDR:

Amashubhu e-Endotracheal okusetshenziswa okukodwa;

Ama-Catheter Suction Oyinyumba Okusetshenziswa Okukodwa;

Amamaski Omoya Wokusetshenziswa Okukodwa;

Ama-Cannula Oxygen Wamakhala Okusetshenziswa Okukodwa;

I-Guedel Airways yokusetshenziswa okukodwa;

I-Laryngeal Mask Airways;

Amamaski Okubulala Izinzwa Zokusetshenziswa Okukodwa;

Izihlungi Zokuphefumula Zokusetshenziswa Okukodwa;

Izifunda Zokuphefumula Zokusetshenziswa Okukodwa;

Ama-Catheter Wokuchama Wokusetshenziswa Okukodwa (Foley).

Isitifiketi se-EU MDR sibonisa ukuthi imikhiqizo ye-Kangyuan Medical ihlangabezana nezidingo zomthethonqubo wakamuva we-EU wedivayisi yezokwelapha 2017/745, inezimo zakamuva zokufinyelela zemakethe ye-EU, futhi ingaqhubeka nokudayiswa ngokusemthethweni ezimakethe zaphesheya kwezilwandle ezifanele, ibeka isisekelo esiqinile ngokuqhubeka nokungena emakethe yaseYurophu kanye nokukhuthaza inqubo yokwenziwa kwamazwe ngamazwe.