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    <deviceName>Time-resolved immunofluorescence analyzer</deviceName>
    <manufacturerName>Bifour Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034957</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)</reference>
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    <tradeName>NOVEOS® Immunoassay System</tradeName>
    <deviceName>NOVEOS® Immunoassay System</deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:23:20.203Z</lastUpdated>
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    <manufacturerName>iSTOC Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000033355</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>012016</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:32.283Z</lastUpdated>
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    <deviceName>dIFine ANCA Classifier</deviceName>
    <manufacturerName>Visia Lab S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000013016</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA08ANCA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:22:13.776Z</lastUpdated>
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    <basicUdiDi>805930434dIFineDNAMX</basicUdiDi>
    <tradeName>08059304340222</tradeName>
    <deviceName>dIFine DNA Classifier</deviceName>
    <manufacturerName>Visia Lab S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000013016</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA08DNA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:22:09.778Z</lastUpdated>
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    <udiDi>08059304340215</udiDi>
    <basicUdiDi>805930434dIFineANAMG</basicUdiDi>
    <tradeName>08059304340215</tradeName>
    <deviceName>dIFine ANA HEp-2 Classifier</deviceName>
    <manufacturerName>Visia Lab S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000013016</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA08ANA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:22:08.971Z</lastUpdated>
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    <tradeName>Phadia Xplain</tradeName>
    <deviceName>Phadia Xplain</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-1013-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:18:17.898Z</lastUpdated>
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    <tradeName>Phadia MIA</tradeName>
    <deviceName>Phadia MIA</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-1009-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:18:15.483Z</lastUpdated>
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    <basicUdiDi>7333066BUDI0016LV</basicUdiDi>
    <tradeName>Phadia Prime</tradeName>
    <deviceName>Phadia Prime</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12-4101-00</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:16:57.790Z</lastUpdated>
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    <udiDi>06947145513597</udiDi>
    <basicUdiDi>69471455Preaccu6W</basicUdiDi>
    <tradeName>Preaccu</tradeName>
    <deviceName>Preaccu for Prenatal Screening</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22010315</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:19:01.895Z</lastUpdated>
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    <udiDi>00816879028768</udiDi>
    <basicUdiDi>081687902NOVINST37</basicUdiDi>
    <tradeName>NOVEOS flex Immunoassay System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FX64000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.857Z</lastUpdated>
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