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| 企业名称 | MHRA参考编号 | 产品名称 | GMDN代码 | 注册日期 | 器械类型 | 风险分类 |
|---|---|---|---|---|---|---|
| ITENA Clinical | 17877 | Resin dental inlay | 38649 | 2021-08-27 | General Medical Device | Class IIa |
| ITENA Clinical | 17877 | Pin/post dental drill bit | 43311 | 2021-08-27 | General Medical Device | Class IIa |
| ITENA Clinical | 17877 | Temporary dental crown/bridge resin | 45236 | 2021-08-27 | General Medical Device | Class IIa |
| ITENA Clinical | 17877 | Calcium hydroxide dental cement | 62199 | 2021-08-27 | General Medical Device | Class IIb |
| ITENA Clinical | 17877 | Dental prosthesis priming agent | 62474 | 2021-08-27 | General Medical Device | Class IIa |
| ITENA Clinical | 17877 | Dental etching solution syringe | 63696 | 2021-08-27 | General Medical Device | Class IIa |
| ITENA Clinical | 17877 | Hygroscopic dental cement | 60510 | 2021-08-27 | General Medical Device | Class IIb |
| Paul Hartmann AG | 12932 | Hevea-latex surgical glove, non-powdered, non-antimicrobial | 47178 | 2021-03-25 | General Medical Device | Class IIa |
| Natera, Inc | 17878 | Human genomic analysis interpretive software | 61777 | 2021-08-27 | In Vitro Diagnostic Device | IVD Annex II List B |
| Natera, Inc | 17878 | Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT) | 59947 | 2021-08-27 | In Vitro Diagnostic Device | IVD Annex II List B |
| Natera, Inc | 17878 | Nucleic acid amplification mastermix kit IVD | 60091 | 2021-08-27 | In Vitro Diagnostic Device | IVD Annex II List B |
| Natera, Inc | 17878 | Nucleic acid amplification primer IVD | 64176 | 2021-08-27 | In Vitro Diagnostic Device | IVD Annex II List B |
| Guangzhou Wondfo Biotech Co., Ltd. | 12536 | Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test | 30512 | 2021-03-07 | In Vitro Diagnostic Device | IVD Devices for Self-Testing |
| Guangzhou Wondfo Biotech Co., Ltd. | 12536 | Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid | 33819 | 2021-03-07 | In Vitro Diagnostic Device | IVD General |
| Guangzhou Wondfo Biotech Co., Ltd. | 12536 | Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid | 33819 | 2021-03-07 | In Vitro Diagnostic Device | IVD Devices for Self-Testing |
| Guangzhou Wondfo Biotech Co., Ltd. | 12536 | Influenza/parainfluenza virus antigen IVD, kit, immunochromatographic test (ICT), rapid | 48258 | 2021-03-07 | In Vitro Diagnostic Device | IVD General |
| Guangzhou Wondfo Biotech Co., Ltd. | 12536 | Helicobacter pylori antigen IVD, kit, rapid ICT, clinical | 30825 | 2021-03-07 | In Vitro Diagnostic Device | IVD General |
| Guangzhou Wondfo Biotech Co., Ltd. | 12536 | Glucose IVD, control | 41819 | 2021-03-07 | In Vitro Diagnostic Device | IVD Annex II List B |
| Guangzhou Wondfo Biotech Co., Ltd. | 12536 | Glucose IVD, reagent | 53307 | 2021-03-07 | In Vitro Diagnostic Device | IVD Annex II List B |
| Guangzhou Wondfo Biotech Co., Ltd. | 12536 | Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical | 54255 | 2021-03-07 | In Vitro Diagnostic Device | IVD Devices for Self-Testing |
