<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R066162W</udiDi>
    <basicUdiDi>B-R066162W</basicUdiDi>
    <tradeName>D-R066162W</tradeName>
    <deviceName>Immunoglobulin G (IgG) Assay Reagent Kit (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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06616</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:56:01.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R066152U</udiDi>
    <basicUdiDi>B-R066152U</basicUdiDi>
    <tradeName>D-R066152U</tradeName>
    <deviceName>Immunoglobulin G (IgG) Assay Reagent Kit (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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06615</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:56:00.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R067122T</udiDi>
    <basicUdiDi>B-R067122T</basicUdiDi>
    <tradeName>D-R067122T</tradeName>
    <deviceName>Immunoglobulin A (IgA) Assay Reagent Kit (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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06713</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:59.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R067112R</udiDi>
    <basicUdiDi>B-R067112R</basicUdiDi>
    <tradeName>D-R067112R</tradeName>
    <deviceName>Immunoglobulin A (IgA) Assay Reagent Kit (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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06711</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:58.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R066142S</udiDi>
    <basicUdiDi>B-R066142S</basicUdiDi>
    <tradeName>D-R066142S</tradeName>
    <deviceName>Immunoglobulin G (IgG) Assay Reagent Kit (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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06614</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:41.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R066132Q</udiDi>
    <basicUdiDi>B-R066132Q</basicUdiDi>
    <tradeName>D-R066132Q</tradeName>
    <deviceName>Immunoglobulin G (IgG) Assay Reagent Kit (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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06613</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:40.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R066122N</udiDi>
    <basicUdiDi>B-R066122N</basicUdiDi>
    <tradeName>D-R066122N</tradeName>
    <deviceName>Immunoglobulin G (IgG) Assay Reagent Kit (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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06612</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:40.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R066112L</udiDi>
    <basicUdiDi>B-R066112L</basicUdiDi>
    <tradeName>D-R066112L</tradeName>
    <deviceName>Immunoglobulin G (IgG) Assay Reagent Kit (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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06611</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:39.291Z</lastUpdated>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <row>
    <udiDi>D-R064172N</udiDi>
    <basicUdiDi>B-R064172N</basicUdiDi>
    <tradeName>D-R064172N</tradeName>
    <deviceName>Cystatin C 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06417</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:28.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R064162L</udiDi>
    <basicUdiDi>B-R064162L</basicUdiDi>
    <tradeName>D-R064162L</tradeName>
    <deviceName>Cystatin C 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06416</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:27.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R064152J</udiDi>
    <basicUdiDi>B-R064152J</basicUdiDi>
    <tradeName>D-R064152J</tradeName>
    <deviceName>Cystatin C 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06415</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:26.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R064142G</udiDi>
    <basicUdiDi>B-R064142G</basicUdiDi>
    <tradeName>D-R064142G</tradeName>
    <deviceName>Cystatin C 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06414</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:22.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R064122C</udiDi>
    <basicUdiDi>B-R064122C</basicUdiDi>
    <tradeName>D-R064122C</tradeName>
    <deviceName>Cystatin C 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06412</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:21.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R064112A</udiDi>
    <basicUdiDi>B-R064112A</basicUdiDi>
    <tradeName>D-R064112A</tradeName>
    <deviceName>Cystatin C 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06411</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:20.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0611523</udiDi>
    <basicUdiDi>B-R0611523</basicUdiDi>
    <tradeName>D-R0611523</tradeName>
    <deviceName>Pre-albumin Assay Reagent Kit (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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06115</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:03.268Z</lastUpdated>
  </row>
</eudamedExport>