688656 科创 浩欧博

    证券代码：688656          证券简称：浩欧博          公告编号：2021-029

          江苏浩欧博生物医药股份有限公司

  关于自愿披露全资子公司获得医疗器械注册证的公告

          本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述

      或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。

        重要内容提示：

        江苏浩欧博生物医药股份有限公司（以下简称“公司”）全资子公司湖南浩

    欧博生物医药有限公司于近日获得湖南省药品监督管理局核准签发的 25 项医疗

    器械注册证，现将有关情况公告如下：

        一、  医疗器械产品注册证书基本信息

        注册人

序号                    产品名称          注册证编号    有效期至    预期用途
        名称

                                                                    用于体外定
                  过敏原特异性 IgE 抗体校                            量检测人血
                  准品及质控品检测试剂盒    湘械注准                清中特异性
 1              （磁微粒化学发光法）    20212402033  2026-11-10  IgE 抗体
                                                                    （sIgE）含
                                                                    量

                                                                    用于体外定
                  过敏原特异性 IgE 抗体磁                            量检测人血
                  微粒及酶结合物试剂盒      湘械注准                清中特异性
 2              （磁微粒化学发光法）    20212402034  2026-11-10  IgE 抗体
                                                                    （sIgE）含
      湖南浩欧博                                                    量

      生物医药有                                                    用于体外定
        限公司                                                      量检测人血

3              屋尘（H1）过敏原特异性  湘械注准                清中过敏原
                IgE 抗体检测试剂盒（磁微  20212402035  2026-11-10  屋尘（H1）
                粒化学发光法）                                    特异性 IgE
                                                                  抗体含量

                                                                  用于体外定
                                                                  量检测人血
                交链孢霉（M6）过敏原特                            清中过敏原
4              异性 IgE 抗体检测试剂盒  湘械注准                交链孢霉
                （磁微粒化学发光法）    20212402036  2026-11-10  （M6）特
                                                                  异性 IgE 抗
                                                                  体含量

                                                                  用于体外定
                                                                  量检测人血
                艾蒿（W6）过敏原特异性  湘械注准                清中过敏原
5              IgE 抗体检测试剂盒（磁微  20212402037  2026-11-10  艾蒿（W6）
                粒化学发光法）                                    特异性 IgE
                                                                  抗体含量

                                                                  用于体外定
                蟹（F23）过敏原特异性                            量检测人血
                IgE 抗体检测试剂盒（磁    湘械注准                清中过敏原
6              微粒化学发光法）        20212402038  2026-11-10  蟹（F23）特
                                                                  异性 IgE 抗
                                                                  体含量

                                                                  用于体外定
                牛奶（F2）过敏原特异性                            量检测人血
                IgE 抗体检测试剂盒（磁    湘械注准                清中过敏原
7              微粒化学发光法）        20212402039              牛奶（F2）
                                                      2026-11-10  特异性 IgE
                                                                  抗体含量

                猫上皮（E1）过敏原特异                            用于体外定
                性 IgE 抗体检测试剂盒                              量检测人血
8              （磁微粒化学发光法）                              清中过敏原
                                        湘械注准                  猫上皮

                                        20212402040  2026-11-10  （E1）特异
                                                                    性 IgE 抗体
                                                                    含量

                                                                    用于体外定
                粉尘螨（D2）过敏原特异                            量检测人血
                性 IgE 抗体检测试剂盒      湘械注准  2026-11-10  清中过敏原
 9              （磁微粒化学发光法）    20212402041              粉尘螨（D2）
                                                                    特异性 IgE
                                                                    抗体含量

                                                                    用于体外定
                屋尘螨（D1）过敏原特异                            量检测人血
                性 IgE 抗体检测试剂盒      湘械注准                清中过敏原
10              （磁微粒化学发光法）    20212402042  2026-11-10  屋尘螨（D1）
                                                                    特异性 IgE
                                                                    抗体含量

                                                                    用于体外定
                烟曲霉（M3）过敏原特                              量检测人血
                异性 IgE 抗体检测试剂盒                            清中过敏原
11              （磁微粒化学发光法）      湘械注准                烟曲霉