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<eudamedExport entity="devices">
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    <basicUdiDi>B-06971225933562</basicUdiDi>
    <tradeName>Nephstar RF Kit</tradeName>
    <deviceName>Nephstar RF Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DK023</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:26:47.128Z</lastUpdated>
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  <row>
    <udiDi>06971225930691</udiDi>
    <basicUdiDi>B-06971225930691</basicUdiDi>
    <tradeName>Omlipo RF Kit</tradeName>
    <deviceName>Omlipo RF Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP23100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:22:17.293Z</lastUpdated>
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    <udiDi>06971225930684</udiDi>
    <basicUdiDi>B-06971225930684</basicUdiDi>
    <tradeName>Omlipo RF Kit</tradeName>
    <deviceName>Omlipo RF Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP23050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:22:16.360Z</lastUpdated>
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    <udiDi>06971225930387</udiDi>
    <basicUdiDi>B-06971225930387</basicUdiDi>
    <tradeName>GPP-100 RF Kit</tradeName>
    <deviceName>GPP-100 RF Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GP23020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:21:19.724Z</lastUpdated>
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  <row>
    <udiDi>05404035100844</udiDi>
    <basicUdiDi>B-05404035100844</basicUdiDi>
    <tradeName>Waaler Rose</tradeName>
    <deviceName>Waaler Rose</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22162</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:31:38.118Z</lastUpdated>
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  <row>
    <udiDi>04260658557943</udiDi>
    <basicUdiDi>B-04260658557943</basicUdiDi>
    <tradeName>Atlas RF Latex Kit, 125 Tests (5 ml Latex, 2x1 ml controls, Glass slide, Stirring sticks).</tradeName>
    <deviceName>Atlas RF Latex Kit, 125 Tests (5 ml Latex, 2x1 ml controls, Glass slide, Stirring sticks).</deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.04.3.0125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:53:53.975Z</lastUpdated>
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  <row>
    <udiDi>06944904037424</udiDi>
    <basicUdiDi>69449040004GRF*********PB</basicUdiDi>
    <tradeName>Rheumatoid Factor Kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002161-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:58.575Z</lastUpdated>
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    <udiDi>06944904037547</udiDi>
    <basicUdiDi>69449040004GRF*********PB</basicUdiDi>
    <tradeName>Rheumatoid Factor Kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002177-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:58.359Z</lastUpdated>
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  <row>
    <udiDi>06944904037561</udiDi>
    <basicUdiDi>69449040004GRF*********PB</basicUdiDi>
    <tradeName>Rheumatoid Factor Kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002179-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:58.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904037813</udiDi>
    <basicUdiDi>69449040004GRF*********PB</basicUdiDi>
    <tradeName>RF Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-003683-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:58.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904053554</udiDi>
    <basicUdiDi>69449040004MRF*********W9</basicUdiDi>
    <tradeName>Rheumatoid Factor Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004633-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:27.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904053561</udiDi>
    <basicUdiDi>69449040004MRF*********W9</basicUdiDi>
    <tradeName>Rheumatoid Factor Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004634-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:27.172Z</lastUpdated>
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  <row>
    <udiDi>06944904053677</udiDi>
    <basicUdiDi>69449040004MRF*********W9</basicUdiDi>
    <tradeName>Rheumatoid Factor Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004645-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:26.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325003897</udiDi>
    <basicUdiDi>B-04049325003897</basicUdiDi>
    <tradeName>Rheumatoid Factor IgA/IgG/IgM ELISA</tradeName>
    <deviceName>Rheumatoid Factor IgA/IgG/IgM ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE70341</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:09:11.737Z</lastUpdated>
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  <row>
    <udiDi>04049198014235</udiDi>
    <basicUdiDi>B-04049198014235</basicUdiDi>
    <tradeName>04049198014235</tradeName>
    <deviceName>Rheumatoid Factor IgA ELISA</deviceName>
    <manufacturerName>Demeditec Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE7630</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:07:50.034Z</lastUpdated>
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  <row>
    <udiDi>03610230004814</udiDi>
    <basicUdiDi>B-03610230004814</basicUdiDi>
    <tradeName>ABX Pentra RF CP</tradeName>
    <deviceName>ABX Pentra RF CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01613</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:59:01.875Z</lastUpdated>
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  <row>
    <udiDi>D-02B0029YZ</udiDi>
    <basicUdiDi>B-02B0029YZ</basicUdiDi>
    <tradeName>D-02B0029YZ</tradeName>
    <deviceName>C-Reactive Protein/Anti-streptolysin O/Rheumatoid Factor Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2U001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:29:26.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0136D</udiDi>
    <basicUdiDi>B-0136D</basicUdiDi>
    <tradeName>D-0136D</tradeName>
    <deviceName>EasyMagPlex Rheumatoid Arthritis IgM Kit</deviceName>
    <manufacturerName>Hunan Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045201</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>341401HNE,341402HNE,341403HNE,341404HNE,341405HNE,341406HNE</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:09:25.129Z</lastUpdated>
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  <row>
    <udiDi>D-0126B</udiDi>
    <basicUdiDi>B-0126B</basicUdiDi>
    <tradeName>D-0126B</tradeName>
    <deviceName>EasyMagPlex Rheumatoid Arthritis IgG Kit</deviceName>
    <manufacturerName>Hunan Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045201</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>341501HNE,341502HNE,341503HNE,341504HNE,341505HNE,341506HNE</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:09:23.533Z</lastUpdated>
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    <udiDi>00816426021457</udiDi>
    <basicUdiDi>B-00816426021457</basicUdiDi>
    <tradeName>K-ASSAY RF (Ver.2)</tradeName>
    <deviceName>RF (Ver.2) Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-230</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:21.408Z</lastUpdated>
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</eudamedExport>