D-IVD53-02-10tB7 B-IVD53-02-10tB7 Singclean® FLU A/B Antigen Test Kit（Colloidal Gold ） Hangzhou Singclean Medical Products Co., Ltd. CN-MF-000014098 SUNGO Europe B.V. NL-AR-000000247 IVD Genel IVDD W0105099004 INFLUENZA A AND /OR B - RT & POC Piyasada IVD53-02-10t Germany 2026-07-13T23:16:18.982Z D-ITB-402SL B-ITB-402SL D-ITB-402SL TB Tuberculosis Rapid Test Device (Whole Blood/Serum/Plasma) Abon Biopharm(Hangzhou) Co., Ltd CN-MF-000009171 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Genel IVDD W0105090199 BACTERIOLOGY - RT & POC - OTHER Piyasada ITB-402 Germany 2026-07-13T22:43:16.053Z D-ISY-U401RL B-ISY-U401RL D-ISY-U401RL Syphilis Ultra Rapid Test Strip (Whole Blood/Serum/Plasma) Abon Biopharm(Hangzhou) Co., Ltd CN-MF-000009171 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Genel IVDD W0105090105 SYPHILIS - RT & POC Piyasada ISY-U401 Germany 2026-07-13T22:43:02.428Z D-ISY-8032V B-ISY-8032V D-ISY-8032V Syphilis Rapid Test (Oral Fluid) Hangzhou Alltest Biotech.Co.,Ltd. CN-MF-000010710 VidaQuick Biotech S.L. ES-AR-000048138 IVD Genel IVDD W0105090105 SYPHILIS - RT & POC Piyasada ISY-803 Germany 2026-07-13T22:43:01.644Z D-IST-502YJ B-IST-502YJ D-IST-502YJ Strep A Rapid Test Device (Throat Swab) Abon Biopharm(Hangzhou) Co., Ltd CN-MF-000009171 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Genel IVDD W0105090103 STREP. A - RT & POC Piyasada IST-502 Germany 2026-07-13T22:42:57.664Z D-IST-501YG B-IST-501YG D-IST-501YG Strep A Rapid Test Strip (Throat Swab) Abon Biopharm(Hangzhou) Co., Ltd CN-MF-000009171 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Genel IVDD W0105090103 STREP. A - RT & POC Piyasada IST-501 Germany 2026-07-13T22:42:56.855Z D-ISCOVu005G B-ISCOVu005G COVID-19 Antigen Rapid Test COVID-19 Antigen Rapid Test Hangzhou Clongene Biotech Co., Ltd. CN-MF-000030069 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Kendi Kendine Test IVDD W0105099099 VIROLOGY - RT & POC - OTHER Piyasada ISCOVu002-A001; ISCOVu002-A005; ISCOVu002-A025; ISCOVu002-B001; ISCOVu002-B005; ISCOVu002-B025 Hungary 2026-07-13T22:42:42.596Z D-IRTC-5X5(SSW)X7 B-IRTC-5X5(SSW)X7 D-IRTC-5X5(SSW)X7 Multiplex Respiratory Antigen Rapid Test Hangzhou Alltest Biotech.Co.,Ltd. CN-MF-000010710 VidaQuick Biotech S.L. ES-AR-000048138 IVD Genel IVDD W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC Piyasada IRTC-5X5(SSW) Germany 2026-07-13T22:40:32.758Z D-INCP-RG502CE B-INCP-RG502CE SARS-CoV-2 (COVID-19) Antigen Rapid Test SARS-CoV-2 (COVID-19) Antigen Rapid Test Hangzhou Alltest Biotech.Co.,Ltd. CN-MF-000010710 VidaQuick Biotech S.L. ES-AR-000048138 IVD Genel IVDD W0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC Piyasada INCP-RG502 Austria 2026-07-13T22:39:26.253Z D-IMXG-R402HE B-IMXG-R402HE Monkeypox Virus Antigen Rapid Test Monkeypox Virus Antigen Rapid Test Hangzhou Alltest Biotech.Co.,Ltd. CN-MF-000010710 VidaQuick Biotech S.L. ES-AR-000048138 IVD Genel IVDD W0105099008 MONKEYPOX VIRUS / MPOX RT & POC Piyasada IMXG-R402 Austria 2026-07-13T22:39:17.455Z D-IMPV-R402K9 B-IMPV-R402K9 Malaria P.f. /P.v. Rapid Test Cassette Malaria P.f. /P.v. Rapid Test Cassette Hangzhou Alltest Biotech.Co.,Ltd. CN-MF-000010710 VidaQuick Biotech S.L. ES-AR-000048138 IVD Genel IVDD W0105090401 PLASMODIUM (MALARIA) - RT & POC Piyasada IMPV-R402 Austria 2026-07-13T22:39:15.063Z D-IMXB-R402FD B-IMXB-R402FD Monkeypox Virus Antibody Rapid Test Monkeypox Virus Antibody Rapid Test Hangzhou Alltest Biotech.Co.,Ltd. CN-MF-000010710 VidaQuick Biotech S.L. ES-AR-000048138 IVD Genel IVDD W0105099008 MONKEYPOX VIRUS / MPOX RT & POC Piyasada IMXB-R402 Austria 2026-07-13T22:39:13.454Z D-IMPN-401M8 B-IMPN-401M8 D-IMPN-401M8 Malaria P.f./Pan Rapid Test Dipstick Hangzhou Alltest Biotech.Co.,Ltd. CN-MF-000010710 VidaQuick Biotech S.L. ES-AR-000048138 IVD Genel IVDD W0105090401 PLASMODIUM (MALARIA) - RT & POC Piyasada IMPN-401 Spain 2026-07-13T22:39:12.649Z D-IMPN-R402FZ B-IMPN-R402FZ Malaria P.f./Pan Rapid Test Cassette Malaria P.f./Pan Rapid Test Cassette Hangzhou Alltest Biotech.Co.,Ltd. CN-MF-000010710 VidaQuick Biotech S.L. ES-AR-000048138 IVD Genel IVDD W0105090401 PLASMODIUM (MALARIA) - RT & POC Piyasada IMPN-R402 Austria 2026-07-13T22:39:11.048Z D-IMA-R402C3 B-IMA-R402C3 Malaria P.f. Rapid Test Cassette Malaria P.f. Rapid Test Cassette Hangzhou Alltest Biotech.Co.,Ltd. CN-MF-000010710 VidaQuick Biotech S.L. ES-AR-000048138 IVD Genel IVDD W0105090401 PLASMODIUM (MALARIA) - RT & POC Piyasada Alltest Croatia 2026-07-13T22:38:40.583Z D-IIN-501SC B-IIN-501SC D-IIN-501SC Influenza A & B Rapid Test Strip (Swab) Abon Biopharm(Hangzhou) Co., Ltd CN-MF-000009171 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Genel IVDD W0105099004 INFLUENZA A AND /OR B - RT & POC Piyasada IIN-501 Germany 2026-07-13T22:09:47.604Z D-IHP-402SJ B-IHP-402SJ D-IHP-402SJ H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) Abon Biopharm(Hangzhou) Co., Ltd CN-MF-000009171 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Genel IVDD W0105090102 H. PYLORI - RT & POC Piyasada IHP-402 Germany 2026-07-13T22:09:41.226Z D-IHIV-C42M4 B-IHIV-C42M4 RightSign HIV 1.2.O Rapid Test Caseette(Whole Blood/Serum/Plasma) HangZhou Biotest  Biotech Co.,Ltd. CN-MF-000008191 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Ek II Liste A IVDD W0105090302 HIV 1 / 2 - RT & POC Piyasada IHIV-C42 Germany 2026-07-13T22:09:39.599Z D-IHCV-C31JH B-IHCV-C31JH RightSign HCV Rapid Test Cassette(Serum/Plasma) HangZhou Biotest  Biotech Co.,Ltd. CN-MF-000008191 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Ek II Liste A IVDD W0105090202 HCV ANTIBODY -RT & POC Piyasada IHCV-C31 Germany 2026-07-13T22:09:34.805Z D-IHBSG-C31AR B-IHBSG-C31AR RightSign HBsAg Rapid Test Cassette(Serum/Plasma) HangZhou Biotest  Biotech Co.,Ltd. CN-MF-000008191 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Ek II Liste A IVDD W0105090201 HBSAG - RT & POC Piyasada IHBSG-C31 Germany 2026-07-13T22:09:34.069Z