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 00850027856124 0850027856MkD6W Fluxergy Analyzer Fluxergy Analyzer Fluxergy Inc. US-MF-000010833 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Sınıf A IVDR 2017/746 W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER Piyasada 5506-CE Greece 2026-07-16T03:21:51.228Z 00814695024933 081469502STPK8 SureTyper™ SureTyper Software One Lambda, Inc. US-MF-000024901 MDSS GmbH DE-AR-000005430 IVD Sınıf C IVDR 2017/746 W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada STTPGRX Austria 2026-07-16T01:18:08.385Z 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 07332940001865 081164701-XPERTCHECK-3B Xpert® Xpert® Check Cepheid US-MF-000010979 Cepheid AB SE-AR-000048904 IVD Sınıf A IVDR 2017/746 W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER Piyasada XPERTCHECK-CE-5 Netherlands 2026-07-16T01:13:25.640Z 07350148190006 07350148191KA 07350148190006 Qlucore Diagnostics Platform Qlucore AB(publ) SE-MF-000030781 IVD Sınıf A IVDR 2017/746 W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada QD Platform, Denmark 2026-07-16T00:02:41.159Z 30382904419920 038290ZMTAUZEXRG FOX BD FOX™ PCR Extraction Tubes Becton, Dickinson and Company US-MF-000018910 Becton Dickinson Ireland Limited IE-AR-000007610 IVD Sınıf A IVDR 2017/746 W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES Piyasada 441992 Belgium 2026-07-15T20:49:58.959Z 30382904411290 038290OJLDQOTODD FOX BD FOX™ Extraction Tubes Becton, Dickinson and Company US-MF-000018910 Becton Dickinson Ireland Limited IE-AR-000007610 IVD Sınıf A IVDR 2017/746 W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES Piyasada 441129 Belgium 2026-07-15T20:49:58.179Z 30382904375196 038290YMCUPXTNQ8 Not Applicable BD PCR Cartridge Becton, Dickinson and Company US-MF-000018910 Becton Dickinson Ireland Limited IE-AR-000007610 IVD Sınıf A IVDR 2017/746 W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES Piyasada 437519 Belgium 2026-07-15T20:49:54.144Z 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