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<eudamedExport entity="devices">
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    <udiDi>06944904030050</udiDi>
    <basicUdiDi>69449040XQSJ-004DM-6S**X8</basicUdiDi>
    <tradeName>M-68DS DILUENT</tradeName>
    <deviceName>Haematology Reagents</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-001974-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:00:00.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053024709</udiDi>
    <basicUdiDi>69449040XQSJ-CLEANSER**T3</basicUdiDi>
    <tradeName>M-53 CLEANSER</tradeName>
    <deviceName>CLEANSER</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-026315-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:56:52.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053024648</udiDi>
    <basicUdiDi>69449040XQSJ-003BM-5S**VC</basicUdiDi>
    <tradeName>M-53LEO(Ⅱ) LYSE</tradeName>
    <deviceName>Hematology Analyzer Reagent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-026318-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:56:48.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053024372</udiDi>
    <basicUdiDi>69449040XQSJ-003SM-3S**62</basicUdiDi>
    <tradeName>M-30D DILUENT</tradeName>
    <deviceName>Haematology Reagents</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-026309-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:56:47.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053022194</udiDi>
    <basicUdiDi>69449040XQSJ-ESRSR*****TA</basicUdiDi>
    <tradeName>ESR Solution Reagent</tradeName>
    <deviceName>ESR Solution Reagent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-026689-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:56:41.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904082981</udiDi>
    <basicUdiDi>69449040AB70000043Q</basicUdiDi>
    <tradeName>LC LYSE</tradeName>
    <deviceName>LC LYSE、CRP Cleanser</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004887-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:54:34.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053121743</udiDi>
    <basicUdiDi>69449040AB75000125Q</basicUdiDi>
    <tradeName>Cleaning Solution B</tradeName>
    <deviceName>Cleaning Solution B</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-056286-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:52:36.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053082631</udiDi>
    <basicUdiDi>69449040AB70000173Z</basicUdiDi>
    <tradeName>M-6LM LYSE</tradeName>
    <deviceName>M-6LM LYSE, M-6FM DYE</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-047976-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:51:36.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053053075</udiDi>
    <basicUdiDi>69449040AB760000262</basicUdiDi>
    <tradeName>EU-20 Diluent</tradeName>
    <deviceName>EU-20 Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-039328-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:50:21.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053038799</udiDi>
    <basicUdiDi>69449040AB76000015Y</basicUdiDi>
    <tradeName>EU-70 Diluent</tradeName>
    <deviceName>EU-70 Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-035270-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:49:10.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053027113</udiDi>
    <basicUdiDi>69449040AB70000103K</basicUdiDi>
    <tradeName>LS LYSE</tradeName>
    <deviceName>LS LYSE</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-023579-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:18.770Z</lastUpdated>
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  <row>
    <udiDi>06903053025713</udiDi>
    <basicUdiDi>69449040AB75000105L</basicUdiDi>
    <tradeName>Sample Diluent</tradeName>
    <deviceName>Sample Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-024614-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:14.762Z</lastUpdated>
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  <row>
    <udiDi>06903053025706</udiDi>
    <basicUdiDi>69449040AB750000963</basicUdiDi>
    <tradeName>Sample Diluent</tradeName>
    <deviceName>Sample Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-024613-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:13.953Z</lastUpdated>
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  <row>
    <udiDi>06903053025669</udiDi>
    <basicUdiDi>69449040AB75000115N</basicUdiDi>
    <tradeName>Clean Solution</tradeName>
    <deviceName>Clean Solution</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-023651-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:13.159Z</lastUpdated>
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  <row>
    <udiDi>06903053010948</udiDi>
    <basicUdiDi>69449040AB700000942</basicUdiDi>
    <tradeName>DCT DILUENT</tradeName>
    <deviceName>DCT DILUENT</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-020869-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:06.866Z</lastUpdated>
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    <udiDi>06925794577993</udiDi>
    <basicUdiDi>69422022W010301010504R07Q</basicUdiDi>
    <tradeName>BF-SLS-I Lyse</tradeName>
    <deviceName>BF-SLS-I Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019948</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:59.936Z</lastUpdated>
  </row>
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    <udiDi>06925794577986</udiDi>
    <basicUdiDi>69422022W010301010513R07S</basicUdiDi>
    <tradeName>Lyse</tradeName>
    <deviceName>Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019915</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:57.542Z</lastUpdated>
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  <row>
    <udiDi>06925794577948</udiDi>
    <basicUdiDi>69422022W010301010512R07M</basicUdiDi>
    <tradeName>BF-SLS-II Lyse</tradeName>
    <deviceName>BF-SLS-II Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019922</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:55.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794577917</udiDi>
    <basicUdiDi>69422022W010301010508R08C</basicUdiDi>
    <tradeName>BF-FBH Lyse</tradeName>
    <deviceName>BF-FBH Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019905</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:55.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794577900</udiDi>
    <basicUdiDi>69422022W010301010505R07V</basicUdiDi>
    <tradeName>BF-FDOI Lyse</tradeName>
    <deviceName>BF-FDOI Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019957</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:55.431Z</lastUpdated>
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</eudamedExport>