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<eudamedExport entity="devices">
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    <basicUdiDi>150995901447450L8</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447450</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:24:29.924Z</lastUpdated>
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    <udiDi>06936895305262</udiDi>
    <basicUdiDi>B-06936895305262</basicUdiDi>
    <tradeName>Lipoprotein a (Lp(a)) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Lipoprotein a (Lp(a)) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:5mL×4（710）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:00:07.940Z</lastUpdated>
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    <udiDi>06936895305255</udiDi>
    <basicUdiDi>B-06936895305255</basicUdiDi>
    <tradeName>Lipoprotein a (Lp(a)) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Lipoprotein a (Lp(a)) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:64mL×2  R2:16mL×2（794）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:00:07.165Z</lastUpdated>
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    <udiDi>08431673940072</udiDi>
    <basicUdiDi>B-08431673940072</basicUdiDi>
    <tradeName>Lp(a)-TURBI</tradeName>
    <deviceName>Lipoprotein a</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD1107020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:26:42.334Z</lastUpdated>
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    <udiDi>08431673370206</udiDi>
    <basicUdiDi>B-08431673370206</basicUdiDi>
    <tradeName>Lp(a)-TURBI</tradeName>
    <deviceName>Lipoprotein a</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK1107020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:23:04.361Z</lastUpdated>
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  <row>
    <udiDi>08431673170219</udiDi>
    <basicUdiDi>B-08431673170219</basicUdiDi>
    <tradeName>Lp(a)-TURBI</tradeName>
    <deviceName>Lipoprotein a</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP1107020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:21:34.623Z</lastUpdated>
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    <udiDi>08431673170202</udiDi>
    <basicUdiDi>B-08431673170202</basicUdiDi>
    <tradeName>Lp(a)-TURBI</tradeName>
    <deviceName>Lipoprotein a</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1107020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:21:30.630Z</lastUpdated>
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  <row>
    <udiDi>08431673079161</udiDi>
    <basicUdiDi>B-08431673079161</basicUdiDi>
    <tradeName>Lp(a)-TURBI</tradeName>
    <deviceName>Lipoprotein a</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI1107020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:16:19.773Z</lastUpdated>
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  <row>
    <udiDi>00630414595559</udiDi>
    <basicUdiDi>0405686901741VT</basicUdiDi>
    <tradeName>Atellica CH Lipoprotein(a) (Lp(a))</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_LPA</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097627</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:19.396Z</lastUpdated>
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  <row>
    <udiDi>D-R065162R</udiDi>
    <basicUdiDi>B-R065162R</basicUdiDi>
    <tradeName>D-R065162R</tradeName>
    <deviceName>Lipoprotein(a) Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06516</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:35.306Z</lastUpdated>
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  <row>
    <udiDi>D-R065152P</udiDi>
    <basicUdiDi>B-R065152P</basicUdiDi>
    <tradeName>D-R065152P</tradeName>
    <deviceName>Lipoprotein(a) Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06515</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:34.503Z</lastUpdated>
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  <row>
    <udiDi>D-R065142M</udiDi>
    <basicUdiDi>B-R065142M</basicUdiDi>
    <tradeName>D-R065142M</tradeName>
    <deviceName>Lipoprotein(a) Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06514</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:33.721Z</lastUpdated>
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  <row>
    <udiDi>D-R065122H</udiDi>
    <basicUdiDi>B-R065122H</basicUdiDi>
    <tradeName>D-R065122H</tradeName>
    <deviceName>Lipoprotein(a) Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06512</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:32.890Z</lastUpdated>
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  <row>
    <udiDi>D-R065112F</udiDi>
    <basicUdiDi>B-R065112F</basicUdiDi>
    <tradeName>D-R065112F</tradeName>
    <deviceName>Lipoprotein(a) Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06511</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:28.886Z</lastUpdated>
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    <udiDi>80536177214642Q</udiDi>
    <basicUdiDi>B-80536177214642Q</basicUdiDi>
    <tradeName>Lp (a)</tradeName>
    <deviceName>Lp (a)</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB1057</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:32:38.338Z</lastUpdated>
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  <row>
    <udiDi>D-6-42AA</udiDi>
    <basicUdiDi>B-6-42AA</basicUdiDi>
    <tradeName>D-6-42AA</tradeName>
    <deviceName>Liporotein (a) Test Kit (Immunoturbidimetric Assay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U83482040M, U83489060M, U83485020M, U83420060M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:12:54.976Z</lastUpdated>
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    <udiDi>05415168014960</udiDi>
    <basicUdiDi>B-05415168014960</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/OPT</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:54:13.552Z</lastUpdated>
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    <udiDi>05415168014953</udiDi>
    <basicUdiDi>B-05415168014953</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/OPT</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:54:11.945Z</lastUpdated>
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    <udiDi>05415168014946</udiDi>
    <basicUdiDi>B-05415168014946</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/OPT</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:54:11.147Z</lastUpdated>
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    <udiDi>00842768007552</udiDi>
    <basicUdiDi>0405686900885WD</basicUdiDi>
    <tradeName>N Latex Lp(a) Reagent</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG _N_La_Lpa</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446069</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:40.739Z</lastUpdated>
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