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    <tradeName>FraiyaScan</tradeName>
    <deviceName>FraiyaScan</deviceName>
    <manufacturerName>Fraiya Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045978</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FraiyaScan</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:08:50.425Z</lastUpdated>
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    <udiDi>04260346620010</udiDi>
    <basicUdiDi>426034662TriumCTGOnlineQU</basicUdiDi>
    <tradeName>Trium CTG Online</tradeName>
    <deviceName>Trium CTG Online</deviceName>
    <manufacturerName>Trium Analysis Online GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007016</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002001E-02-4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:54:01.214Z</lastUpdated>
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    <udiDi>03760415600031</udiDi>
    <basicUdiDi>376041560BVCMD01AM</basicUdiDi>
    <tradeName>B-Right Views Fetal Heart</tradeName>
    <deviceName>BrightHeart View Classifier (B-Right Views Fetal Heart)</deviceName>
    <manufacturerName>BrightHeart</manufacturerName>
    <manufacturerSrn>FR-MF-000044855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BVCMD01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:04:48.963Z</lastUpdated>
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    <udiDi>03760415600024</udiDi>
    <basicUdiDi>376041560FESMD01BC</basicUdiDi>
    <tradeName>B-Right Screen Fetal Heart</tradeName>
    <deviceName>Fetal EchoScan (B-Right Screen Fetal Heart)</deviceName>
    <manufacturerName>BrightHeart</manufacturerName>
    <manufacturerSrn>FR-MF-000044855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FESMD01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:04:48.166Z</lastUpdated>
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    <udiDi>00884838084490</udiDi>
    <basicUdiDi>B-00884838084490</basicUdiDi>
    <tradeName>IntelliSpace Perinatal K Small Arch.</tradeName>
    <deviceName>IntelliSpace Perinatal</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>867062</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:05:11.497Z</lastUpdated>
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  <row>
    <udiDi>00884838084483</udiDi>
    <basicUdiDi>B-00884838084483</basicUdiDi>
    <tradeName>IntelliSpace Perinatal K Large Arch.</tradeName>
    <deviceName>IntelliSpace Perinatal</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>867061</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:05:07.507Z</lastUpdated>
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  <row>
    <udiDi>04260748856000</udiDi>
    <basicUdiDi>426074885astneonCL</basicUdiDi>
    <tradeName>astraia neon</tradeName>
    <deviceName>astraia neon</deviceName>
    <manufacturerName>NEXUS / ASTRAIA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007042</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.0.x</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:09:46.175Z</lastUpdated>
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    <udiDi>04260748850008</udiDi>
    <basicUdiDi>426074885ASTRAIASC</basicUdiDi>
    <tradeName>astraia – software for women's health - obstetric and gynaecological database application</tradeName>
    <deviceName>astraia – software for women's health</deviceName>
    <manufacturerName>NEXUS / ASTRAIA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007042</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.27.4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:09:42.163Z</lastUpdated>
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    <udiDi>03770033463024</udiDi>
    <basicUdiDi>3770033463FETOLYv2ZB</basicUdiDi>
    <tradeName>03770033463024</tradeName>
    <deviceName>FETOLY</deviceName>
    <manufacturerName>DIAGNOLY</manufacturerName>
    <manufacturerSrn>FR-MF-000037822</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FETOLY</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:14:21.695Z</lastUpdated>
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    <udiDi>03770033463000</udiDi>
    <basicUdiDi>3770033463FETOLY4K</basicUdiDi>
    <tradeName>03770033463000</tradeName>
    <deviceName>FETOLY-HEART</deviceName>
    <manufacturerName>DIAGNOLY</manufacturerName>
    <manufacturerSrn>FR-MF-000037822</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FETOLY-HEART</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:14:20.092Z</lastUpdated>
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  <row>
    <udiDi>03770024341034</udiDi>
    <basicUdiDi>3770024341SuspectS6</basicUdiDi>
    <tradeName>Sonio Suspect</tradeName>
    <deviceName>Sonio Suspect</deviceName>
    <manufacturerName>Sonio</manufacturerName>
    <manufacturerSrn>FR-MF-000018467</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:05:39.823Z</lastUpdated>
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  <row>
    <udiDi>03770024341027</udiDi>
    <basicUdiDi>3770024341DetectMM</basicUdiDi>
    <tradeName>Sonio Detect</tradeName>
    <deviceName>Sonio Detect</deviceName>
    <manufacturerName>Sonio</manufacturerName>
    <manufacturerSrn>FR-MF-000018467</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:05:39.030Z</lastUpdated>
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  <row>
    <udiDi>03770024341041</udiDi>
    <basicUdiDi>3770024341DetectMM</basicUdiDi>
    <tradeName>Sonio Detect</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sonio</manufacturerName>
    <manufacturerSrn>FR-MF-000018467</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:21:43.731Z</lastUpdated>
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    <udiDi>03770033463031</udiDi>
    <basicUdiDi>3770033463FETOLYv2ZB</basicUdiDi>
    <tradeName>03770033463031</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIAGNOLY</manufacturerName>
    <manufacturerSrn>FR-MF-000037822</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FETOLY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:54.156Z</lastUpdated>
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    <udiDi>03770033463048</udiDi>
    <basicUdiDi>3770033463FETOLYv2ZB</basicUdiDi>
    <tradeName>FETOLY</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIAGNOLY</manufacturerName>
    <manufacturerSrn>FR-MF-000037822</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FETOLY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T02:20:54.147Z</lastUpdated>
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    <udiDi>04260748850046</udiDi>
    <basicUdiDi>426074885ASTRAIASC</basicUdiDi>
    <tradeName>astraia – software for women's health</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXUS / ASTRAIA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007042</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.00.xx, 30.01.xx</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:05:25.315Z</lastUpdated>
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    <udiDi>04260346620072</udiDi>
    <basicUdiDi>426034662TriumCTGOnlineQU</basicUdiDi>
    <tradeName>Trium CTG Online</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trium Analysis Online GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007016</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002001C-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:23:56.546Z</lastUpdated>
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    <udiDi>04260748850039</udiDi>
    <basicUdiDi>426074885ASTRAIASC</basicUdiDi>
    <tradeName>astraia – software for women's health</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXUS / ASTRAIA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007042</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29.02.00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:22:12.256Z</lastUpdated>
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    <udiDi>04260748850022</udiDi>
    <basicUdiDi>426074885ASTRAIASC</basicUdiDi>
    <tradeName>astraia – software for women's health</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXUS / ASTRAIA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007042</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29.01.00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:22:11.372Z</lastUpdated>
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    <udiDi>04260748850015</udiDi>
    <basicUdiDi>426074885ASTRAIASC</basicUdiDi>
    <tradeName>astraia – software for women's health - obstetric and gynaecological database application</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXUS / ASTRAIA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007042</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29.00.00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:22:10.460Z</lastUpdated>
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