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    <tradeName>Nephstar Lp(a) Kit</tradeName>
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    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <basicUdiDi>B-06971225930783</basicUdiDi>
    <tradeName>Omlipo Lp(a) Kit</tradeName>
    <deviceName>Omlipo Lp(a) Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <udiDi>05907514644827</udiDi>
    <basicUdiDi>B-05907514644827</basicUdiDi>
    <tradeName>PRESTIGE 24i LIPOPROTEIN (a)</tradeName>
    <deviceName>LIPOPROTEIN (a)</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:20:31.867Z</lastUpdated>
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    <udiDi>05907514642632</udiDi>
    <basicUdiDi>B-05907514642632</basicUdiDi>
    <tradeName>PRESTIGE 24i LIPOPROTEIN (a)</tradeName>
    <deviceName>LIPOPROTEIN (a)</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4-263</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:20:30.270Z</lastUpdated>
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    <udiDi>05415168015554</udiDi>
    <basicUdiDi>B-05415168015554</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-L00/COB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:30.852Z</lastUpdated>
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    <udiDi>05415168013987</udiDi>
    <basicUdiDi>B-05415168013987</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-L00/AU</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:26.061Z</lastUpdated>
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    <udiDi>05415168013970</udiDi>
    <basicUdiDi>B-05415168013970</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-B00/AU</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:25.258Z</lastUpdated>
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    <udiDi>05415168011136</udiDi>
    <basicUdiDi>B-05415168011136</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-L00/CGR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:24.455Z</lastUpdated>
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    <udiDi>05415168011129</udiDi>
    <basicUdiDi>B-05415168011129</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-H00/CGR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:20.897Z</lastUpdated>
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    <udiDi>05415168011112</udiDi>
    <basicUdiDi>B-05415168011112</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-B00/CGR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:20.244Z</lastUpdated>
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    <udiDi>05415168010191</udiDi>
    <basicUdiDi>B-05415168010191</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-L00/ATE</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:19.140Z</lastUpdated>
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    <udiDi>05415168010184</udiDi>
    <basicUdiDi>B-05415168010184</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-H00/ATE</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:13.246Z</lastUpdated>
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    <udiDi>05415168010177</udiDi>
    <basicUdiDi>B-05415168010177</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-B00/ATE</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:12.511Z</lastUpdated>
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    <udiDi>05415168009461</udiDi>
    <basicUdiDi>B-05415168009461</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-L00/ARC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:10.843Z</lastUpdated>
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    <udiDi>05415168009010</udiDi>
    <basicUdiDi>B-05415168009010</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-L00/ALI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:33:44.087Z</lastUpdated>
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    <udiDi>05415168008549</udiDi>
    <basicUdiDi>B-05415168008549</basicUdiDi>
    <tradeName>Lipoprotein (a)</tradeName>
    <deviceName>Lipoprotein (a)</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:33:41.497Z</lastUpdated>
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    <udiDi>05415168008075</udiDi>
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    <tradeName>Lipoprotein (a)</tradeName>
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    <manufacturerName>Diagam S.A.</manufacturerName>
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    <lastUpdated>2026-07-06T05:33:39.898Z</lastUpdated>
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    <udiDi>05415168006439</udiDi>
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    <tradeName>Lipoprotein (a)</tradeName>
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    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:33:33.487Z</lastUpdated>
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    <tradeName>Lipoprotein (a)</tradeName>
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    <manufacturerName>Diagam S.A.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T05:33:31.098Z</lastUpdated>
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    <tradeName>Lipoprotein (a)</tradeName>
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    <manufacturerName>Diagam S.A.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPTUR2-B00/UDA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:33:22.282Z</lastUpdated>
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