2023年1月,国家药监局共批准注册医疗器械产品124个。其中,境内第三类医疗器械产品99个,进口第三类医疗器械产品11个,进口第二类医疗器械产品12个,港澳台医疗器械产品2个(具体产品见附件)。
序号 | 产品名称 | 注册人名称 | 注册证编号 |
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| 二十项遗传性耳聋基因突变检测试剂盒(飞行时间质谱法) | | |
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| 丙型肝炎病毒抗体(Anti-HCV)检测试剂盒(化学发光法) | | |
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| 人类ALDH2基因多态性检测试剂盒(荧光PCR法) | | |
| 游离前列腺特异性抗原测定试剂盒(磁微粒化学发光法) | | |
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| 弓形虫、风疹病毒、巨细胞病毒、单纯疱疹病毒I型、单纯疱疹病毒II型IgM抗体质控品 | | |
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| 新型冠状病毒(2019-nCoV)、甲型流感病毒和乙型流感病毒核酸检测试剂盒(荧光PCR法) | | |
| 新型冠状病毒(2019-nCoV)核酸检测试剂盒(荧光PCR法) | | |
| 新型冠状病毒(2019-nCoV)抗原检测试剂盒(胶体金法) | | |
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| 甲胎蛋白(AFP)测定试剂盒(化学发光免疫分析法) | | |
| 弓形虫、风疹病毒、巨细胞病毒、单纯疱疹病毒I型、单纯疱疹病毒II型IgG抗体质控品 | | |
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| | St. Jude Medical Coordination Center BVBA | |
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| | Becton Dickinson and Company | |
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| | Boston Scientific Corporation | |
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| | St.Jude Medical Coordination Center BVBA | |
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| | Medtronic Powered Surgical Solutions | |
| | Micro Therapeutics, Inc.DBA ev3 Neurovascular | |
| | Seawon Meditech Co., Ltd. | |
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| | Siemens Healthcare Diagnostics Inc. | |
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| | VAREX IMAGING CORPORATION | |
| | Argon Medical Devices, Inc. | |
| | Jadran-Galenski laboratorij d.d. | |
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