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    <basicUdiDi>692591270023GV</basicUdiDi>
    <tradeName>iFlash-CEA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86004-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:09.758Z</lastUpdated>
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  <row>
    <udiDi>06925912723189</udiDi>
    <basicUdiDi>692591270026H3</basicUdiDi>
    <tradeName>iFlash-CA 19-9</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86007-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:09.725Z</lastUpdated>
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  <row>
    <udiDi>06925912723196</udiDi>
    <basicUdiDi>692591270024GX</basicUdiDi>
    <tradeName>iFlash-CA 125</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86005-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:09.701Z</lastUpdated>
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    <udiDi>06925912723325</udiDi>
    <basicUdiDi>692591270027H5</basicUdiDi>
    <tradeName>iFlash-CYFRA 21-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86028-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:09.342Z</lastUpdated>
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  <row>
    <udiDi>06925912723936</udiDi>
    <basicUdiDi>692591270097HS</basicUdiDi>
    <tradeName>iFlash-Total PSA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86000-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:13.203Z</lastUpdated>
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  <row>
    <udiDi>06925912723943</udiDi>
    <basicUdiDi>692591270098HU</basicUdiDi>
    <tradeName>iFlash-Free PSA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86001-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:13.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350066140401</udiDi>
    <basicUdiDi>B-17350066140401</basicUdiDi>
    <tradeName>CanAg SCC EIA</tradeName>
    <deviceName>CanAg SCC EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:14:51.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350066140289</udiDi>
    <basicUdiDi>B-17350066140289</basicUdiDi>
    <tradeName>CanAg CEA EIA</tradeName>
    <deviceName>CanAg CEA EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:14:30.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350066140241</udiDi>
    <basicUdiDi>B-17350066140241</basicUdiDi>
    <tradeName>CanAg CA125 EIA</tradeName>
    <deviceName>CanAg CA125 EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:14:28.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350066140159</udiDi>
    <basicUdiDi>B-17350066140159</basicUdiDi>
    <tradeName>CanAg ProGRP EIA</tradeName>
    <deviceName>CanAg ProGRP EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030121</emdnCode>
    <emdnDescription>PRO-GASTRIN-RELEASING PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:14:28.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350066140081</udiDi>
    <basicUdiDi>B-17350066140081</basicUdiDi>
    <tradeName>CanAg CA15-3 EIA</tradeName>
    <deviceName>CanAg CA15-3 EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:14:26.531Z</lastUpdated>
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  <row>
    <udiDi>17350066140050</udiDi>
    <basicUdiDi>B-17350066140050</basicUdiDi>
    <tradeName>CanAg CA19-9 EIA</tradeName>
    <deviceName>CanAg CA19-9 EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:14:24.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350066140012</udiDi>
    <basicUdiDi>B-17350066140012</basicUdiDi>
    <tradeName>CanAg CA242 EIA</tradeName>
    <deviceName>CanAg CA242 EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:14:21.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763662</udiDi>
    <basicUdiDi>B-15065023763662</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>CEA Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20028</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:36:08.328Z</lastUpdated>
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  <row>
    <udiDi>14562185399551</udiDi>
    <basicUdiDi>B-14562185399551</basicUdiDi>
    <tradeName>14562185399551</tradeName>
    <deviceName>CL AIA-PACK free PSA ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029217</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:05:55.083Z</lastUpdated>
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    <udiDi>14562185399544</udiDi>
    <basicUdiDi>B-14562185399544</basicUdiDi>
    <tradeName>14562185399544</tradeName>
    <deviceName>CL AIA-PACK free PSA TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029117</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:05:54.284Z</lastUpdated>
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    <udiDi>14562185399537</udiDi>
    <basicUdiDi>B-14562185399537</basicUdiDi>
    <tradeName>14562185399537</tradeName>
    <deviceName>CL AIA-PACK PSA ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029216</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:05:53.482Z</lastUpdated>
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    <udiDi>14562185399520</udiDi>
    <basicUdiDi>B-14562185399520</basicUdiDi>
    <tradeName>14562185399520</tradeName>
    <deviceName>CL AIA-PACK PSA TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029116</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:05:52.682Z</lastUpdated>
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    <udiDi>14562185399513</udiDi>
    <basicUdiDi>B-14562185399513</basicUdiDi>
    <tradeName>14562185399513</tradeName>
    <deviceName>CL AIA-PACK OVCA ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029215</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:05:47.881Z</lastUpdated>
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    <udiDi>14562185399506</udiDi>
    <basicUdiDi>B-14562185399506</basicUdiDi>
    <tradeName>14562185399506</tradeName>
    <deviceName>CL AIA-PACK OVCA TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029115</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:05:47.080Z</lastUpdated>
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