O royin pe Haiyan Kangyuan Medical Instrument Co., Ltd. ti ni aṣeyọri gba ijẹrisi CE ti Ilana Ẹrọ Egbogi EU 2017/745 (ti a tọka si bi “MDR”) ni awọn ọja meji ni oṣu to kọja. Awọn ọja jẹ PVC Laryngeal Mask Airways ati Latex Foley Catheters fun Lilo Nikan. Ni bayi, awọn ọja 12 ti Kangyuan Medical ti kọja iwe-ẹri MDR, eyiti o jẹ atẹle yii:
[Awọn tubes Endotracheal fun Lilo Nikan];
[Sterile Suction Catheters fun Nikan Lo];
[Awọn iboju iparada fun lilo Nikan];
[Nasal atẹgun Cannulas fun Nikan Lo];
[Guedel Airways fun Nikan Lo];
[Laryngeal Mask Airways];
[Awọn iboju iparada fun Lilo Nikan];
[Awọn Ajọ Mimi fun Lilo Nikan];
[Awọn iyika Mimi fun Lilo Nikan];
[Awọn Catheters ito fun Lilo Nikan (Foley)];
[Latex Foley Catheters fun Nikan Lo];
[Awọn oju opopona PVC Laryngeal Maski]
Ijẹrisi MDR EU fihan pe awọn ọja Iṣoogun Kangyuan pade awọn ibeere ti ilana ẹrọ iṣoogun EU tuntun 2017/745 ati ni awọn ipo iwọle tuntun fun ọja EU. Eyi kii ṣe idanimọ giga nikan ti didara, ailewu ati imunadoko ti awọn ọja iṣoogun Kangyuan, ṣugbọn tun jẹ afihan pataki ti agbara imọ-ẹrọ ti ile-iṣẹ ati ifigagbaga ọja. Iṣoogun Kangyuan yoo lo aye yii lati faagun ọja Yuroopu siwaju ati pese awọn iṣẹ iṣoogun ti o ga julọ si awọn alaisan diẹ sii ni ayika agbaye.
Akoko ifiweranṣẹ: Oṣu Kẹjọ-19-2024