<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R054152B</udiDi>
    <basicUdiDi>B-R054152B</basicUdiDi>
    <tradeName>D-R054152B</tradeName>
    <deviceName>Bile Acids Assay Reagent Kit (5th Generation Colorimetric Method)</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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05415</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:56.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0541225</udiDi>
    <basicUdiDi>B-R0541225</basicUdiDi>
    <tradeName>D-R0541225</tradeName>
    <deviceName>Bile Acids Assay Reagent Kit (5th Generation Colorimetric Method)</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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05412</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:39.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0541123</udiDi>
    <basicUdiDi>B-R0541123</basicUdiDi>
    <tradeName>D-R0541123</tradeName>
    <deviceName>Bile Acids Assay Reagent Kit (5th Generation Colorimetric Method)</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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05411</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:39.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0531424</udiDi>
    <basicUdiDi>B-R0531424</basicUdiDi>
    <tradeName>D-R0531424</tradeName>
    <deviceName>Bicarbonate Assay Reagent Kit (PEPC Enzymatic)</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>W01010302</emdnCode>
    <emdnDescription>BICARBONATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05314</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:38.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0531322</udiDi>
    <basicUdiDi>B-R0531322</basicUdiDi>
    <tradeName>D-R0531322</tradeName>
    <deviceName>Bicarbonate Assay Reagent Kit (PEPC Enzymatic)</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>W01010302</emdnCode>
    <emdnDescription>BICARBONATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05313</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:37.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05312ZV</udiDi>
    <basicUdiDi>B-R05312ZV</basicUdiDi>
    <tradeName>D-R05312ZV</tradeName>
    <deviceName>Bicarbonate Assay Reagent Kit (PEPC Enzymatic)</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>W01010302</emdnCode>
    <emdnDescription>BICARBONATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05312</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:33.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05311ZT</udiDi>
    <basicUdiDi>B-R05311ZT</basicUdiDi>
    <tradeName>D-R05311ZT</tradeName>
    <deviceName>Bicarbonate Assay Reagent Kit (PEPC Enzymatic)</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>W01010302</emdnCode>
    <emdnDescription>BICARBONATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05311</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:32.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05214ZU</udiDi>
    <basicUdiDi>B-R05214ZU</basicUdiDi>
    <tradeName>D-R05214ZU</tradeName>
    <deviceName>Cholinesterase Assay Reagent Kit (Butyrylthiocholine Method)</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>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05214</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:31.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05213ZS</udiDi>
    <basicUdiDi>B-R05213ZS</basicUdiDi>
    <tradeName>D-R05213ZS</tradeName>
    <deviceName>Cholinesterase Assay Reagent Kit (Butyrylthiocholine Method)</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>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05213</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:31.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05212ZQ</udiDi>
    <basicUdiDi>B-R05212ZQ</basicUdiDi>
    <tradeName>D-R05212ZQ</tradeName>
    <deviceName>Cholinesterase Assay Reagent Kit (Butyrylthiocholine Method)</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>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05212</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:27.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05211ZN</udiDi>
    <basicUdiDi>B-R05211ZN</basicUdiDi>
    <tradeName>D-R05211ZN</tradeName>
    <deviceName>Cholinesterase Assay Reagent Kit (Butyrylthiocholine Method)</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>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05211</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:26.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05114ZP</udiDi>
    <basicUdiDi>B-R05114ZP</basicUdiDi>
    <tradeName>D-R05114ZP</tradeName>
    <deviceName>Direct Bilirubin Assay Reagent Kit (Oxidation to Biliverdin Method)</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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05114</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:25.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05113ZM</udiDi>
    <basicUdiDi>B-R05113ZM</basicUdiDi>
    <tradeName>D-R05113ZM</tradeName>
    <deviceName>Direct Bilirubin Assay Reagent Kit (Oxidation to Biliverdin Method)</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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05113</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:24.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05112ZK</udiDi>
    <basicUdiDi>B-R05112ZK</basicUdiDi>
    <tradeName>D-R05112ZK</tradeName>
    <deviceName>Direct Bilirubin Assay Reagent Kit (Oxidation to Biliverdin Method)</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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05112</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:20.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05111ZH</udiDi>
    <basicUdiDi>B-R05111ZH</basicUdiDi>
    <tradeName>D-R05111ZH</tradeName>
    <deviceName>Direct Bilirubin Assay Reagent Kit (Oxidation to Biliverdin Method)</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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05111</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:19.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05014ZJ</udiDi>
    <basicUdiDi>B-R05014ZJ</basicUdiDi>
    <tradeName>D-R05014ZJ</tradeName>
    <deviceName>Total Bilirubin Assay Reagent Kit (Oxidation to Biliverdin Method)</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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05014</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:19.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05012ZE</udiDi>
    <basicUdiDi>B-R05012ZE</basicUdiDi>
    <tradeName>D-R05012ZE</tradeName>
    <deviceName>Total Bilirubin Assay Reagent Kit (Oxidation to Biliverdin Method)</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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05012</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:18.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R05011ZC</udiDi>
    <basicUdiDi>B-R05011ZC</basicUdiDi>
    <tradeName>D-R05011ZC</tradeName>
    <deviceName>Total Bilirubin Assay Reagent Kit (Oxidation to Biliverdin Method)</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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R05011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:14.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R049142T</udiDi>
    <basicUdiDi>B-R049142T</basicUdiDi>
    <tradeName>D-R049142T</tradeName>
    <deviceName>Apolipoprotein B 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>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R04914</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:13.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R049122P</udiDi>
    <basicUdiDi>B-R049122P</basicUdiDi>
    <tradeName>D-R049122P</tradeName>
    <deviceName>Apolipoprotein B 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>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R04912</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:12.643Z</lastUpdated>
  </row>
</eudamedExport>