06970895476065 B-06970895476065 06970895476065 Urological and Reproductive Tract Microbial Nucleic Acid Test Kit(Fluorescent Probe-Based Real-Time PCR Assay) Jiangsu Mole Bioscience Co., LTD. CN-MF-000001539 Medunion S.L. ES-AR-000019366 IVD Genel IVDD W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada S08202T2024 Czechia 2026-07-06T08:40:48.656Z 04049055003679 B-04049055003679 FluoroType® STI VER 1.0 FluoroType® STI VER 1.0 Hain Lifescience GmbH DE-MF-000008606 IVD Ek II Liste B IVDD W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada 1877362 Germany 2026-07-06T00:04:20.243Z D-000012807174097QV B-000012807174097QV 14 Kinds of Genitourinary Tract Infection Pathogen Nucleic Acid Detection Kit (Fluorescence PCR) 14 Kinds of Genitourinary Tract Infection Pathogen Nucleic Acid Detection Kit (Fluorescence PCR) Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. CN-MF-000012807 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada HWTS-UR040 Spain 2026-07-04T05:59:18.831Z 09352224000078 9352224011210WD PlexPCR VHS (550) PlexPCR VHS SpeeDx Pty. Ltd. AU-MF-000016649 MedEnvoy Global BV NL-AR-000024028 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada 1123001 Netherlands 2026-07-03T21:07:09.566Z 08908015304132 89080153043B291NQ TRUPCR® STD Panel Kit TRUPCR® STD Panel Kit 3B BlackBio Dx Limited IN-MF-000023698 Wellkang Ltd XI-AR-000001836 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada 3B291/C Germany 2026-07-03T19:06:30.946Z 15420045512832 54200455DIAGAPTCOMBO2P8 Aptima Combo 2 Assay Aptima Combo 2 Assay Hologic US-MF-000001646 Hologic BV BE-AR-000000127 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada PRD-05571 Belgium 2026-07-02T01:06:30.162Z 15420045512061 54200455DIAGAPTCVTV2E Aptima CV/TV Assay Aptima CV/TV Assay Hologic US-MF-000001646 Hologic BV BE-AR-000000127 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada PRD-05189 Belgium 2026-07-02T01:06:24.565Z 03532670103578 353267F00204P7T BIOSYNEX AMPLIQUICK STI Panel I BIOSYNEX FR-MF-000014073 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada 3150070_SEC01 France 2026-07-01T09:25:27.348Z 08809240103685 924010SD10367H5 Allplex™ NG & DR Assay Allplex™ NG & DR Assay Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada SD10368Z Germany 2026-07-01T03:13:21.849Z 08809240103678 924010SD10367H5 Allplex™ NG & DR Assay Allplex™ NG & DR Assay Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada SD10367X Germany 2026-07-01T03:13:15.851Z 08809240103180 924010SD10202G4 Allplex™ STI Essential Assay Q(MH,UU) Allplex™ STI Essential Assay Q(MH,UU) Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada SD10318Z Germany 2026-07-01T03:13:13.448Z 08809240103173 924010SD94000KA Allplex™ CT/NG/MG/TV Assay Allplex™ CT/NG/MG/TV Assay Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada SD10317Z Germany 2026-07-01T03:13:12.261Z 08809240103005 924010SD94000KA Allplex™ CT/NG/MG/TV Assay Allplex™ CT/NG/MG/TV Assay Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada SD9400X Germany 2026-07-01T03:13:06.236Z 08809240102992 924010SD94000KA Allplex™ CT/NG/MG/TV Assay Allplex™ CT/NG/MG/TV Assay Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada SD9400Y Germany 2026-07-01T03:13:05.041Z 08809240102985 924010SD10202G4 Allplex™ STI Essential Assay Q(MH,UU) Allplex™ STI Essential Assay Q(MH,UU) Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada SD10202X Germany 2026-07-01T03:13:03.834Z 08809240102978 924010SD10202G4 Allplex™ STI Essential Assay Q(MH,UU) Allplex™ STI Essential Assay Q(MH,UU) Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada SD10201Y Germany 2026-07-01T03:13:02.645Z 08809240102961 924010SD98010L9 Allplex™ STI Essential Assay Allplex™ STI Essential Assay Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada SD10245Z Germany 2026-07-01T03:12:56.634Z 08809240102954 924010SD98010L9 Allplex™ STI Essential Assay Allplex™ STI Essential Assay Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada SD9801X Germany 2026-07-01T03:12:55.432Z 08809240102947 924010SD98010L9 Allplex™ STI Essential Assay Allplex™ STI Essential Assay Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada SD9801Y Germany 2026-07-01T03:12:54.237Z 08800111719004 88001117IPCA01MA10X9 STANDARD™ M10 STI Panel STANDARD™ M10 STI Panel SD Biosensor Inc. KR-MF-000009168 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada 11STI10A Italy 2026-07-01T02:32:57.186Z