15420045512894 54200455DIAGAPTCOMBO2P8 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-05576 2026-06-29T19:47:58.307Z 15420045512078 54200455DIAGAPTCVTV2E 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 2026-06-29T10:22:16.653Z 15420045512092 54200455DIAGAPTCVTV2E Aptima CV/TV Assay Controls Kit 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-05190 2026-06-29T10:22:16.611Z 15420045517073 54200455DIAGAPTCVTV2E 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-07665 2026-06-29T10:22:16.131Z 15420045517080 54200455DIAGAPTCVTV2E 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-07665 2026-06-29T10:22:16.103Z 08908015304927 89080153043B291NQ 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 2026-06-29T08:20:06.712Z 08908015304934 89080153043B291NQ 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 3B292 2026-06-29T08:20:06.687Z 06955792731103 B-06955792731103 Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing) Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing) Sansure Biotech Inc. CN-MF-000011392 Obelis s.a. BE-AR-000000106 IVD Ek II Liste B IVDD W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada S3050E Italy 2026-06-28T17:29:59.724Z 03532670103585 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_SEC02 2026-06-28T08:40:55.923Z 03532670103592 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_BLK100 2026-06-28T08:40:55.898Z 06950996004510 B-06950996004510 Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method) Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 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 2RET9A11 Ireland 2026-06-28T06:33:04.991Z 00884999047945 0884999AMN0917XS Alinity m Abbott Molecular Inc. US-MF-000017776 Abbott GmbH DE-AR-000009457 IVD Sınıf C IVDR 2017/746 W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada 09N17-090 2026-06-19T19:48:41.723Z 09352224000146 9352224011210WD PlexPCR VHS(610) 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 1121001 2026-06-16T21:08:37.669Z 09352224000153 9352224011210WD PlexPCR VHS(675) 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 1125001 2026-06-16T21:08:37.625Z 09352224001310 9352224011210WD PlexPCR VHS (7500) 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 99004 2026-06-16T21:08:37.576Z 09352224001327 9352224011210WD PLexPCR VHS (LC480) 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 99005 2026-06-16T21:08:37.546Z 09352224001334 9352224011210WD PlexPCR VHS (CFX) 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 99006 2026-06-16T21:08:37.479Z 15420045512085 54200455DIAGAPTCVTV2E Aptima CV/TV Assay Calibrator 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-05191 2026-06-16T15:39:57.499Z