<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R1581234</udiDi>
    <basicUdiDi>B-R1581234</basicUdiDi>
    <tradeName>D-R1581234</tradeName>
    <deviceName>Insulin Reagent Kit (Chemiluminescent Immunoassay )</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>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15812</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:27.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1581132</udiDi>
    <basicUdiDi>B-R1581132</basicUdiDi>
    <tradeName>D-R1581132</tradeName>
    <deviceName>Insulin Reagent Kit (Chemiluminescent Immunoassay )</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>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15811</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:25.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1571637</udiDi>
    <basicUdiDi>B-R1571637</basicUdiDi>
    <tradeName>D-R1571637</tradeName>
    <deviceName>C-Peptide Reagent Kit (Chemiluminescent Immunoassay)</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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15716</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:25.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1571535</udiDi>
    <basicUdiDi>B-R1571535</basicUdiDi>
    <tradeName>D-R1571535</tradeName>
    <deviceName>C-Peptide Reagent Kit (Chemiluminescent Immunoassay)</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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15715</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:21.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1571433</udiDi>
    <basicUdiDi>B-R1571433</basicUdiDi>
    <tradeName>D-R1571433</tradeName>
    <deviceName>C-Peptide Reagent Kit (Chemiluminescent Immunoassay)</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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15714</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:20.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R157132Z</udiDi>
    <basicUdiDi>B-R157132Z</basicUdiDi>
    <tradeName>D-R157132Z</tradeName>
    <deviceName>C-Peptide Reagent Kit (Chemiluminescent Immunoassay)</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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15713</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:19.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R157122X</udiDi>
    <basicUdiDi>B-R157122X</basicUdiDi>
    <tradeName>D-R157122X</tradeName>
    <deviceName>C-Peptide Reagent Kit (Chemiluminescent Immunoassay)</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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15712</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:18.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R157112V</udiDi>
    <basicUdiDi>B-R157112V</basicUdiDi>
    <tradeName>D-R157112V</tradeName>
    <deviceName>C-Peptide Reagent Kit (Chemiluminescent Immunoassay)</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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15711</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:14.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414966045</udiDi>
    <basicUdiDi>0405686901396VY</basicUdiDi>
    <tradeName>IMMULITE 2000 Insulin</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_Insulin</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381455</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:51.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961873</udiDi>
    <basicUdiDi>0405686901375VQ</basicUdiDi>
    <tradeName>IMMULITE 2000 C-Peptide</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_C-Peptide</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381450</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:45.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414600413</udiDi>
    <basicUdiDi>0405686901607VN</basicUdiDi>
    <tradeName>Atellica IM C-peptide (CpS)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_KIT_C-Peptide</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995541</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:08:50.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414461021</udiDi>
    <basicUdiDi>0405686900789WG</basicUdiDi>
    <tradeName>ADVIA Centaur Insulin</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_IRI</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10310439</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:48:32.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935784461003</udiDi>
    <basicUdiDi>B-06935784461003</basicUdiDi>
    <tradeName>06935784461003</tradeName>
    <deviceName>Insulin Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:57.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935784460907</udiDi>
    <basicUdiDi>B-06935784460907</basicUdiDi>
    <tradeName>06935784460907</tradeName>
    <deviceName>C-Peptide Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S021</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:56.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771200097</udiDi>
    <basicUdiDi>B-08056771200097</basicUdiDi>
    <tradeName>LIAISON® C-Peptid</tradeName>
    <deviceName>LIAISON® C-Peptid</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>316171</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:29:49.040Z</lastUpdated>
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  <row>
    <udiDi>00630414600444</udiDi>
    <basicUdiDi>0405686900789WG</basicUdiDi>
    <tradeName>Atellica IM Insulin (IRI)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_IRI</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995628</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:15:02.208Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000014455-BF-S025RF</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S025RF</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S025RF</tradeName>
    <deviceName>Insulin Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:48:28.925Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000014455-BF-S024RD</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S024RD</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S024RD</tradeName>
    <deviceName>C-Peptide Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S024</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:48:26.022Z</lastUpdated>
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    <udiDi>D-CNMF000014455-BF-S023RB</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S023RB</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S023RB</tradeName>
    <deviceName>C-Peptide Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S023</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:48:23.148Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000014455-BF-S022R9</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S022R9</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S022R9</tradeName>
    <deviceName>C-Peptide Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S022</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:48:20.696Z</lastUpdated>
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</eudamedExport>