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    <basicUdiDi>150995902B46435RX</basicUdiDi>
    <tradeName>Urine/CSF Albumin</tradeName>
    <deviceName>Urine/CSF Albumin</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B46435</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:30:18.575Z</lastUpdated>
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    <udiDi>15099590012076</udiDi>
    <basicUdiDi>150995902B38858T2</basicUdiDi>
    <tradeName>Urine/CSF Albumin</tradeName>
    <deviceName>Urine/CSF Albumin</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B38858</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:29:33.695Z</lastUpdated>
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    <udiDi>15099590010706</udiDi>
    <basicUdiDi>150995901OSR6175MJ</basicUdiDi>
    <tradeName>Prealbumin</tradeName>
    <deviceName>Prealbumin</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6175</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:56.857Z</lastUpdated>
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    <udiDi>15099590010614</udiDi>
    <basicUdiDi>150995901OSR6164MD</basicUdiDi>
    <tradeName>Ceruloplasmin</tradeName>
    <deviceName>Ceruloplasmin</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>W0102010301</emdnCode>
    <emdnDescription>CERULOPLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6164</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:51.376Z</lastUpdated>
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    <udiDi>15099590010621</udiDi>
    <basicUdiDi>150995901OSR6165MF</basicUdiDi>
    <tradeName>Haptoglobin</tradeName>
    <deviceName>Haptoglobin</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>W0102010302</emdnCode>
    <emdnDescription>HAPTOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6165</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:48.048Z</lastUpdated>
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    <udiDi>15099590010492</udiDi>
    <basicUdiDi>150995901OSR6152M6</basicUdiDi>
    <tradeName>Transferrin</tradeName>
    <deviceName>Transferrin</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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6152</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:27.889Z</lastUpdated>
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    <udiDi>15099590231897</udiDi>
    <basicUdiDi>150995901447440L5</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems PAB Prealbumin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems PAB Prealbumin 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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447440</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:13.193Z</lastUpdated>
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    <udiDi>15099590230456</udiDi>
    <basicUdiDi>150995901446480LA</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems HPT Haptoglobin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems HPT Haptoglobin 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>W0102010302</emdnCode>
    <emdnDescription>HAPTOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>446480</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:06.779Z</lastUpdated>
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  <row>
    <udiDi>15099590180171</udiDi>
    <basicUdiDi>150995901447630LC</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems TRF Transferrin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems TRF Transferrin 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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447630</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:24:28.314Z</lastUpdated>
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  <row>
    <udiDi>15099590180164</udiDi>
    <basicUdiDi>150995901447690LW</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems MA Microalbumin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems MA Microalbumin 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>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447690</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:24:25.911Z</lastUpdated>
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  <row>
    <udiDi>00842768006258</udiDi>
    <basicUdiDi>0405686900929W8</basicUdiDi>
    <tradeName>Dimension Vista Transferrin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_MAR EB_B_KIT_V_TRF</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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445910</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:25:34.854Z</lastUpdated>
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  <row>
    <udiDi>00842768006210</udiDi>
    <basicUdiDi>0405686900921VQ</basicUdiDi>
    <tradeName>Dimension Vista Prealbumin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_MAR EB_B_KIT_V_PREALB</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445906</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:25:33.000Z</lastUpdated>
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  <row>
    <udiDi>00842768006203</udiDi>
    <basicUdiDi>0405686900920VN</basicUdiDi>
    <tradeName>Dimension Vista Microalbumin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_MAR EB_C_KIT_V_MALB</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445905</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:25:17.762Z</lastUpdated>
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    <udiDi>00842768006111</udiDi>
    <basicUdiDi>0405686900913VR</basicUdiDi>
    <tradeName>Dimension Vista Haptoglobin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_MAR EB_B_KIT_V_HAPT</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>W0102010302</emdnCode>
    <emdnDescription>HAPTOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:25:11.343Z</lastUpdated>
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    <udiDi>86060147127046</udiDi>
    <basicUdiDi>B-86060147127046</basicUdiDi>
    <tradeName>Hemoglobin/Haptoglobin Complex</tradeName>
    <deviceName>Hemoglobin/Haptoglobin Complex</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010302</emdnCode>
    <emdnDescription>HAPTOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N1812HBHP</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:08:00.878Z</lastUpdated>
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    <udiDi>86060313277148</udiDi>
    <basicUdiDi>B-86060313277148</basicUdiDi>
    <tradeName>Hemoglobin/Haptoglobin Complex</tradeName>
    <deviceName>Hemoglobin/Haptoglobin Complex</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010302</emdnCode>
    <emdnDescription>HAPTOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1812HBHP</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:51.383Z</lastUpdated>
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    <udiDi>06936895306054</udiDi>
    <basicUdiDi>B-06936895306054</basicUdiDi>
    <tradeName>Microalbuminuria (MALB) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Microalbuminuria (MALB) 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>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:70ml×6   R2:42ml×2（795）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:58:15.361Z</lastUpdated>
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    <udiDi>06936895306047</udiDi>
    <basicUdiDi>B-06936895306047</basicUdiDi>
    <tradeName>Microalbuminuria (MALB) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Microalbuminuria (MALB) 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>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:25mL×4  R2:5mL×4（796）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:58:13.761Z</lastUpdated>
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    <udiDi>84352873318051</udiDi>
    <basicUdiDi>B-84352873318051</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>Transferrin at</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84352873318051</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:18:22.146Z</lastUpdated>
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    <udiDi>84352873318044</udiDi>
    <basicUdiDi>B-84352873318044</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>Transferrin at</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR31680</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:18:21.341Z</lastUpdated>
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