00857167005382 085716700510107545001KP cobas® eplex system cobas® eplex system GenMark Diagnostics US-MF-000010772 Emergo Europe B.V. NL-AR-000000116 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada 10107545001 Netherlands 2026-07-16T03:41:43.994Z 00857167005009 0857167005RM0030017M ePlex Instrument ePlex Instrument GenMark Diagnostics US-MF-000010772 Emergo Europe B.V. NL-AR-000000116 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada RM003001 Netherlands 2026-07-16T03:41:42.397Z 00850049735629 0850049735AC-61000ET6 HighPrep PCR - DX (1000 mL) HighPrep PCR - DX (1000 mL) MagBio Genomics, Inc. US-MF-000038221 CEpartner4U NL-AR-000000111 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada AC-61000E Germany 2026-07-16T03:30:01.751Z 00850045030650 0850045030AC-60001E96 HighPrep PCR - DX (1 mL) HighPrep PCR - DX (1 mL) MagBio Genomics, Inc. US-MF-000038221 CEpartner4U NL-AR-000000111 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada AC-60001E Germany 2026-07-16T03:29:26.865Z 00850045030148 0850045030AC-60250EAA HighPrep PCR - DX (250 mL) HighPrep PCR - DX (250 mL) MagBio Genomics, Inc. US-MF-000038221 CEpartner4U NL-AR-000000111 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada AC-60250E Germany 2026-07-16T03:29:24.813Z 00850045030155 0850045030AC-60500EA6 HighPrep PCR - DX (500 mL) HighPrep PCR - DX (500 mL) MagBio Genomics, Inc. US-MF-000038221 CEpartner4U NL-AR-000000111 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada AC-60500E Germany 2026-07-16T03:29:22.502Z 00850045030131 0850045030AC-60050E9U HighPrep PCR - DX (50 mL) HighPrep PCR - DX (50 mL) MagBio Genomics, Inc. US-MF-000038221 CEpartner4U NL-AR-000000111 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada AC-60050E Germany 2026-07-16T03:29:08.738Z 00850045030124 0850045030AC-60005E9J HighPrep PCR - DX (5 mL) HighPrep PCR - DX (5 mL) MagBio Genomics, Inc. US-MF-000038221 CEpartner4U NL-AR-000000111 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada AC-60005E Germany 2026-07-16T03:29:06.342Z 00850045030056 0850045030AC-60100E9A HighPrep PCR - DX (100 mL) HighPrep PCR - DX (100 mL) MagBio Genomics, Inc. US-MF-000038221 CEpartner4U NL-AR-000000111 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada AC-60100E Germany 2026-07-16T03:29:02.347Z 07332940007713 081164701-INFINITY-ZH GeneXpert® GeneXpert® Infinity Systems Cepheid US-MF-000010979 Cepheid AB SE-AR-000048904 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada GX-INFINITY 48S Netherlands 2026-07-16T01:13:39.942Z 07332940007683 081164701-GX-X5 GeneXpert GeneXpert® Dx Systems Cepheid US-MF-000010979 Cepheid AB SE-AR-000048904 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada GeneXpert II (GX-II) Netherlands 2026-07-16T01:13:38.488Z 00382904439903 038290TFCJEOYLAA COR BD COR™ GX INSTRUMENT Becton, Dickinson and Company US-MF-000018910 Becton Dickinson Ireland Limited IE-AR-000007610 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada 443990 Belgium 2026-07-15T20:44:06.306Z 00382904419165 038290UZTXHTZA26 MAX BD MAX™ System Becton, Dickinson and Company US-MF-000018910 Becton Dickinson Ireland Limited IE-AR-000007610 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada 441916 Belgium 2026-07-15T20:43:51.205Z 00192721001470 0192721U0200100NL PGDx elio tissue complete PGDx elio tissue complete Personal Genome Diagnostics, Inc. US-MF-000026862 Emergo Europe B.V. NL-AR-000000116 IVD Sınıf C IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada B01102200 Germany 2026-07-15T20:03:19.029Z 10190302018838 0190302A50534RM Applied Biosystems™ SeqStudio™ 8 Flex Dx Genetic Analyzer Applied Biosystems™ SeqStudio™ Flex Dx Series Genetic Analyzer Life Technologies Holdings Pte Ltd SG-MF-000023931 Life Technologies Europe B.V. NL-AR-000021890 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada A50534 Netherlands 2026-07-15T19:50:51.634Z 10190302016148 0190302TCF00005354P QuantStudio™ 7 Pro Dx Real‑Time PCR Instrument QuantStudio™ 7 Pro Dx Real-Time PCR Instrument and Accessories Life Technologies Holdings Pte Ltd SG-MF-000023931 Life Technologies Europe B.V. NL-AR-000021890 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada A50745 Netherlands 2026-07-15T19:50:05.869Z 10190302015592 0190302A47326SJ QuantStudio™ 5 Dx Real‑Time PCR Instrument (96-Well 0.2ml Block) QuantStudio™ 5 Dx Real-Time PCR System and Accessories Life Technologies Holdings Pte Ltd SG-MF-000023931 Life Technologies Europe B.V. NL-AR-000021890 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada A47324 (A47326, A47327) Netherlands 2026-07-15T19:50:03.457Z 10190302005937 0190302TCF00005084L 3500 Dx Genetic Analyzer Applied Biosystems™ 3500 Dx/3500xL Dx Genetic Analyzers Life Technologies Holdings Pte Ltd SG-MF-000023931 Life Technologies Europe B.V. NL-AR-000021890 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada 4405182 (A27772) Netherlands 2026-07-15T19:49:49.889Z 10190302000833 0190302A25511RB Ion PGM™ Dx Sequencer Ion Personal Genome Machine (PGM™) Dx Instrument System Life Technologies Holdings Pte Ltd SG-MF-000023931 Life Technologies Europe B.V. NL-AR-000021890 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada 4485656 Netherlands 2026-07-15T19:49:38.650Z 00840733102318 008407331REVOGENECLA001TF Revogene® Revogene® Meridian Bioscience Inc. US-MF-000044096 Meridian Bioscience Europe S.r.l. IT-AR-000010460 IVD Sınıf A IVDR 2017/746 W02050116 NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS Piyasada 610210 Italy 2026-07-15T19:25:03.944Z