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河北康卫仕医疗科技有限公司

境内医疗器械(注册) — “冀械注准20202220473”基本信息
注册证编号冀械注准20202220473 [查看相关产品信息]
注册人名称河北康卫仕医疗科技有限公司[查看公司信息]
注册人住所河北省石家庄市元氏县经济开发区诚信产业园益鑫路8号
生产地址河北省石家庄市元氏县元氏大街95号
产品名称一次性使用真空采血管
管理类别第二类
型号规格见产品概述
结构及组成/主要组成成分无添加剂(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)促凝管(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)分离胶/促凝剂(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)EDTAK2(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)EDTAK3(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)肝素钠(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)肝素锂(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)EDTAK2/分离胶(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)EDTAK2/氟化钠(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)枸橼酸钠1:4(0.5mL、1.28mL、1.6mL、2mL、2.4mL、3mL、3.2mL、4mL、5mL、6mL、7mL、8mL、9mL、10mL)枸橼酸钠1:9(0.5mL、1.8mL、2mL、2.7mL、3mL、3.6mL、4mL、4.5mL、5mL、6mL、7mL、8mL、9mL、10mL)本品由玻璃试管或PET、丁基胶塞、塑料帽盖、标签、添加剂(如有)及附加物(如有)组成。与采血针配套使用,分别用于临床人体静脉血液标本的采集、抗凝/促凝/分离/保存。分类编码:22-11-04
适用范围/预期用途与采血针配套使用,分别用于临床人体静脉血液标本的采集、抗凝/促凝/分离/保存。
审批部门河北省药品监督管理局
批准日期2020/6/24
生效日期2020/6/24
有效期至2025/6/23
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