<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04015630928347</udiDi>
    <basicUdiDi>761333601372AL</basicUdiDi>
    <tradeName>cobas 8000 ISE 900 Module</tradeName>
    <deviceName>cobas 8000 ISE 900 Module</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010108</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05641497001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:46.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630928255</udiDi>
    <basicUdiDi>761333601371AJ</basicUdiDi>
    <tradeName>cobas 8000 c 701 Module</tradeName>
    <deviceName>cobas 8000 c 701 Module</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010108</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05641489001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:41.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630927289</udiDi>
    <basicUdiDi>761333601343AD</basicUdiDi>
    <tradeName>Reaction Cell c 701 / c 702</tradeName>
    <deviceName>Reaction Cell c 701 / c 702</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010180</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04939719001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:41.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630925551</udiDi>
    <basicUdiDi>761333601323A7</basicUdiDi>
    <tradeName>cobas c 311 analyzer</tradeName>
    <deviceName>cobas c 311 analyzer</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04826876001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:40.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630924110</udiDi>
    <basicUdiDi>761333601327AF</basicUdiDi>
    <tradeName>Reaction Cell c 501 / c 502</tradeName>
    <deviceName>Reaction Cell c 501 / c 502</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Roche Diagnostics GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006262</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010180</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04854241001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:56:34.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978848020372</udiDi>
    <basicUdiDi>6978848020372HJ</basicUdiDi>
    <tradeName>Auto Dry Biochemistry Analyzer</tradeName>
    <deviceName>Auto Dry Biochemistry Analyzer</deviceName>
    <manufacturerName>Seamaty Diagnostic Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047425</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00814000EN0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:05:37.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978848020266</udiDi>
    <basicUdiDi>6978848020266HJ</basicUdiDi>
    <tradeName>Auto Dry Biochemistry Analyzer</tradeName>
    <deviceName>Auto Dry Biochemistry Analyzer</deviceName>
    <manufacturerName>Seamaty Diagnostic Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047425</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00813000EN0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:05:36.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978848020044</udiDi>
    <basicUdiDi>6978848020044GW</basicUdiDi>
    <tradeName>Auto Dry Biochemistry Analyzer</tradeName>
    <deviceName>Auto Dry Biochemistry Analyzer</deviceName>
    <manufacturerName>Seamaty Diagnostic Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047425</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00812000EN0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:05:31.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978848020020</udiDi>
    <basicUdiDi>6978848020020GG</basicUdiDi>
    <tradeName>Auto Chemistry Analyzer</tradeName>
    <deviceName>Auto Chemistry Analyzer</deviceName>
    <manufacturerName>Seamaty Diagnostic Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047425</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00815000EN0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:05:30.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978669682209</udiDi>
    <basicUdiDi>697866968UKCA3S</basicUdiDi>
    <tradeName>Automatic Biochemical Analyzer</tradeName>
    <deviceName>Automatic Biochemical Analyzer</deviceName>
    <manufacturerName>Shenzhen Ukin Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055688</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UKCA 2000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:53:16.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978189070050</udiDi>
    <basicUdiDi>697818907JZCHAWG</basicUdiDi>
    <tradeName>06978189070050</tradeName>
    <deviceName>Microfluidic clinical chemistry analyzer</deviceName>
    <manufacturerName>Yantai JIEZI Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JIE-100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:19:46.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698401003</udiDi>
    <basicUdiDi>697769840GKPD0166E</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName>Dry Fluorescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD016</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:54:23.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907514601707</udiDi>
    <basicUdiDi>59075146Accent400SS</basicUdiDi>
    <tradeName>Chemistry Analyzer ACCENT-400</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010102</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B08-A0002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:41:57.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977149630006</udiDi>
    <basicUdiDi>697714963TKACATK</basicUdiDi>
    <tradeName>TECOM</tradeName>
    <deviceName>Automatic Chemistry Analyzer</deviceName>
    <manufacturerName>Tecom Science Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000038772</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC6090L</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:13:35.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976960820009</udiDi>
    <basicUdiDi>697696082KL7A</basicUdiDi>
    <tradeName>PINNACLES KunLun Automatic Chemistry Analyzer</tradeName>
    <deviceName>Automatic Chemistry Analyzer</deviceName>
    <manufacturerName>Pinnacles (Suzhou) Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039051</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010108</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:05:39.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975838802529</udiDi>
    <basicUdiDi>697583880MS003QU</basicUdiDi>
    <tradeName>06975838802529</tradeName>
    <deviceName>Automated Small Specific Protein Analyzer</deviceName>
    <manufacturerName>Zhejiang Pushkang Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042656</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE10015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:09:17.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975838800631</udiDi>
    <basicUdiDi>697583880MS200QY</basicUdiDi>
    <tradeName>Automated Chemistry Analyzer</tradeName>
    <deviceName>Automated Chemistry Analyzer</deviceName>
    <manufacturerName>Zhejiang Pushkang Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042656</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE10007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:09:15.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975838800624</udiDi>
    <basicUdiDi>697583880MS100QT</basicUdiDi>
    <tradeName>Chemistry Analyzer</tradeName>
    <deviceName>Chemistry Analyzer</deviceName>
    <manufacturerName>Zhejiang Pushkang Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042656</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE10005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:09:14.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975641350101</udiDi>
    <basicUdiDi>697564135ABIOALOC200UC</basicUdiDi>
    <tradeName>Automatic biochemistry analyzer LOC-200</tradeName>
    <deviceName>Automatic biochemistry analyzer LOC-200</deviceName>
    <manufacturerName>Tianjin LOCMEDT Technologies Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025773</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30100005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:26:33.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975569870163</udiDi>
    <basicUdiDi>6975569870528KK</basicUdiDi>
    <tradeName>06975569870163</tradeName>
    <deviceName>Auto Chemistry Analyzer</deviceName>
    <manufacturerName>Shenzhen Sinseng Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000024231</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S120pro</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:17:17.771Z</lastUpdated>
  </row>
</eudamedExport>