05999565781354 599956578002TX NanoTYPER NanoTYPER 2.2.0 CE Omixon Biocomputing Ltd. HU-MF-000003018 IVD Sınıf C IVDR 2017/746 W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada SW6 Hungary 2026-07-31T13:38:26.990Z 05745000468157 5745000468BGISEQ-500PX 05745000468157 sequencing system BGI EUROPE A/S DK-MF-000014089 IVD Sınıf A IVDR 2017/746 W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada BGISEQ-500 Denmark 2026-07-31T09:40:06.219Z 05298004820143 52980048SFTWRUJ VEGA Analysis Software VEGA Analysis Software MEDICOVER GENETICS LIMITED CY-MF-000009381 IVD Sınıf C IVDR 2017/746 W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada Not applicable Cyprus 2026-07-31T06:49:41.192Z 04260563550282 4260563550237VS MH Guide MH Guide Molecular Health GmbH DE-MF-000012861 IVD Sınıf C IVDR 2017/746 W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Artık piyasada değil 1000000128 Germany 2026-07-31T02:28:06.690Z 04260563550275 4260563550237VS MH Guide MH Guide Molecular Health GmbH DE-MF-000012861 IVD Sınıf C IVDR 2017/746 W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Artık piyasada değil 1000000128 Germany 2026-07-31T02:21:02.597Z 04260563550268 4260563550237VS MH Guide MH Guide Molecular Health GmbH DE-MF-000012861 IVD Sınıf C IVDR 2017/746 W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Artık piyasada değil 1000000128 Germany 2026-07-30T23:11:15.164Z 04062996000019 4062996DISQVER5F DISQVER DISQVER Noscendo GmbH DE-MF-000039951 IVD Sınıf C IVDR 2017/746 W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada N/A Germany 2026-07-30T20:13:53.336Z 03573026635046 357302BUDI002042T8 EMAG® SOFTWARE V1.4 EMAG® SOFTWARE V1.4 bioMérieux SA FR-MF-000004436 IVD Sınıf A IVDR 2017/746 W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada 424651 France 2026-07-29T19:53:55.350Z D-SONOGEN_XPER B-SONOGEN_XPER SONOGEN XP SONOGEN XP INTLAB AG CH-MF-000032746 INTLAB Deutschland GmbH DE-AR-000052872 IVD Genel IVDD W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada n.a. Germany 2026-07-23T16:57:24.087Z 50610078000366 B-50610078000366 50610078000366 Congenica Rare Disease Congenica Ltd GB-MF-000026168 Acorn Regulatory Consultancy Services Ltd IE-AR-000000592 IVD Genel IVDD W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada 101 Ireland 2026-07-16T23:33:46.883Z 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 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 NA ++G143TC8RTPCRInstKF T-COR 8 T-COR 8 Tetracore INC US-MF-000023064 Emergo Europe B.V. NL-AR-000000116 IVD Sınıf A IVDR 2017/746 W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada TC-5049-001 Spain 2026-07-15T16:39:26.410Z D-USMF000023929A538508G B-USMF000023929A538508G Low-pass whole-genome aneuploidy Dx Mosaic w1.0 Low-pass whole-genome aneuploidy Dx Mosaic w1.0, a part of Ion Reporter (IR) Software Aneuploidy Dx Workflows Life Technologies Corporation US-MF-000023929 Life Technologies Europe B.V. NL-AR-000021890 IVD Ek II Liste B IVDD W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada A53850 Netherlands 2026-07-15T08:47:34.032Z D-USMF000023929A538488V B-USMF000023929A538488V Low-pass whole-genome aneuploidy Dx w1.0 Low-pass whole-genome aneuploidy Dx w1.0, a part of Ion Reporter (IR) Software Aneuploidy Dx Workflows Life Technologies Corporation US-MF-000023929 Life Technologies Europe B.V. NL-AR-000021890 IVD Ek II Liste B IVDD W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada A53848 Netherlands 2026-07-15T08:47:32.435Z D-CN-MF-000026308-RJ001UD B-CN-MF-000026308-RJ001UD D-CN-MF-000026308-RJ001UD Human EGFR, KRAS, BRAF, NRAS, PIK3CA Gene Mutation Joint Detection Kit Analysis Software Beijing USCI Medical Devices Co., Ltd. CN-MF-000026308 Wellkang Ltd XI-AR-000001836 IVD Genel IVDD W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada USCI-RJ001 Northern Ireland 2026-07-13T02:09:16.013Z D-C2informHS B-C2informHS D-C2informHS C2inform Veracyte, Inc US-MF-000048711 Veracyte Global BV NL-AR-000047758 IVD Genel IVDD W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada C2inform 1.0.0 Netherlands 2026-07-13T00:53:24.267Z D-BE-MF-000020987D8 B-BE-MF-000020987D8 D-BE-MF-000020987D8 FastFinder Platform UgenTec BE-MF-000020987 IVD Genel IVDD W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada N/A Belgium 2026-07-13T00:23:29.605Z D-888501395VELAAQV B-888501395VELAAQV VELA Analytics VELA Analytics Vela Operations Singapore Pte. Ltd. SG-MF-000025684 Vela Diagnostics Germany GmbH DE-AR-000016088 IVD Genel IVDD W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada 480175 Germany 2026-07-12T17:29:40.666Z D-888501395SSQRep78 B-888501395SSQRep78 Sentosa SQ Reporter Software Sentosa SQ Reporter Software Vela Operations Singapore Pte. Ltd. SG-MF-000025684 Vela Diagnostics Germany GmbH DE-AR-000016088 IVD Genel IVDD W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE Piyasada 480169, 480183, 480185, 480187, 480204 Germany 2026-07-12T17:29:39.861Z