×£ºØ½ðÄê»áÒ½ÁÆ¿ª¿ÚÐ͵¼Äò¹Ü»ñµÃÅ·ÃËMDR-CEÈÏÖ¤
·¢²¼Ê±¼ä£º2025-05-09 14:55:58 ä¯ÀÀ´ÎÊý£º ´Î
½üÈÕ£¬º£ÑνðÄê»áÒ½ÁÆÆ÷еÓÐÏÞ¹«Ë¾ÓÖÓÐÒ»¿î¡°¿ª¿ÚÐ͵¼Äò¹Ü£¨ÓÖÃû£ºÉöÔìðü¹Ü£©¡±²úƷ˳ÀûÈ¡µÃÅ·ÃËÒ½ÁÆÆ÷е·¨¹æ2017/745£¨¼ò³Æ¡°MDR¡±£©CEÈÏÖ¤Ö¤Ê飬Ŀǰ½ðÄê»áÒ½ÁÆÒÑÓÐ13¿î²úƷͨ¹ýÁËMDRÈÏÖ¤£¬·Ö±ðÊÇ£º
Æø¹Ü²å¹Ü [Endotracheal Tubes for Single Use];
Îü̵¹Ü [Sterile Suction Catheters for Single Use];
ÊäÑõÃæÕÖ [Oxygen Masks for Single Use];
±ÇÑõ¹Ü [Nasal Oxygen Cannulas for Single Use];
¿ÚÑÊÍ¨ÆøµÀ [Guedel Airways for Single Use];
ºíÕÖÆøµÀµ¼¹Ü [Laryngeal Mask Airways];
Âé×íÃæÕÖ [Anesthesia Masks for Single Use];
ºôÎü¹ýÂËÆ÷ [Breathing Filters for Single Use];
ºôÎü»ØÂ· [Breathing Circuits for Single Use];
¹è½ºµ¼Äò¹Ü [Urinary Catheters for Single Use (Foley)];
È齺µ¼Äò¹Ü [Latex Foley Catheters for Single Use];
PVCºíÕÖ [PVC Laryngeal Mask Airways]£»
¿ª¿ÚÐ͵¼Äò¹Ü£¨ÉöÔìðü¹Ü£©[Suprapubic Catheters for Single Use]
»ñµÃÅ·ÃËMDRÈÏÖ¤£¬²»½öÒâζ׎ðÄê»áÒ½ÁÆÒÔÑÏ¿Á±ê×¼Ó®µÃÁËÅ·ÃËÊг¡µÄ¡°Í¨ÐÐÖ¤¡±£¬¸ü±ê־׎ðÄê»áÔÚÒ½ÁÆÆ÷еÁìÓò´ïµ½Á˹ú¼ÊÁìÏÈË®×¼¡£Å·ÃËMDRÈÏÖ¤¶Ô²úÆ·ÖÊÁ¿¡¢°²È«ÐÔÄÜ¡¢ÁÙ´²Êý¾ÝµÈ·½ÃæÓÐ׎üºõ¿Á¿ÌµÄÒªÇ󣬽ðÄê»áÒ½ÁÆÄÜͨ¹ýÈÏÖ¤£¬ÕÃÏÔÁËÆäÇ¿´óµÄ¼¼ÊõʵÁ¦Óë׿ԽµÄ²úÆ·Æ·ÖÊ¡£MDRÈÏÖ¤½«ÖúÁ¦½ðÄê»áÒ½ÁÆÉî¶È´ò¿ªÅ·ÃËÊг¡£¬ÌáÉýÆ·ÅÆ¹ú¼ÊÖªÃû¶È¡£Í¬Ê±£¬Ò²¼¤Àø½ðÄê»áÒ½ÁƳÖÐøÉ¼¼ÊõºÏ¹æ¹ÜÀí£¬¼ÓËÙ¼¼Êõ´´Ð£¬ÒÔ¸ü¸ß±ê×¼ÍÆ½ø¹ú¼Ê»¯Õ½ÂÔ²¼¾Ö£¬ÎªÈ«ÇòÏû·ÑÕß½¡¿µ°²È«ÖþÀθü¼áʵµÄ±£ÕÏ·ÀÏß¡£