<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-17402G2</udiDi>
    <basicUdiDi>B-17402G2</basicUdiDi>
    <tradeName>SPOTCHEM D-00 (SD-9810)</tradeName>
    <deviceName>SPOTCHEM D-00 (SD-9810)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030180</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:09.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105289MT</udiDi>
    <basicUdiDi>B-105289MT</basicUdiDi>
    <tradeName>SPOTCHEM D-03 SET</tradeName>
    <deviceName>SPOTCHEM D-03 SET</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030180</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105289</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:21.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105287MP</udiDi>
    <basicUdiDi>B-105287MP</basicUdiDi>
    <tradeName>SPOTCHEM D-02 SET</tradeName>
    <deviceName>SPOTCHEM D-02 SET</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030180</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105287</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:17.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105285MK</udiDi>
    <basicUdiDi>B-105285MK</basicUdiDi>
    <tradeName>SPOTCHEM D-01 SET</tradeName>
    <deviceName>SPOTCHEM D-01 SET</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030180</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105285</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:16.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-104933MU</udiDi>
    <basicUdiDi>B-104933MU</basicUdiDi>
    <tradeName>SPOTCHEM D-00 QR (SD-9811)</tradeName>
    <deviceName>SPOTCHEM D-00 QR (SD-9811)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030180</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104933</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:02.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510225</udiDi>
    <basicUdiDi>803380351BCAAM200DA0001YV</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA 200 DA (44 Rgt Pos)  p/n 10997-01-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3320001200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:58:01.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510263</udiDi>
    <basicUdiDi>803380351BCAAM200SA000173</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA 200 SA (44 Rgt Pos) p/n 11025-01-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3320001202-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:57:51.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510386</udiDi>
    <basicUdiDi>803380351BCAAMIURADA001T4</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA DA (59 Smp Pos) p/n 10001-02-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3260011200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:57:47.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336179918</udiDi>
    <basicUdiDi>761333601781B9</basicUdiDi>
    <tradeName>cobas pro SBL e 801</tradeName>
    <deviceName>cobas pro SBL e 801</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09211888001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:13.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336179536</udiDi>
    <basicUdiDi>761333602140A4</basicUdiDi>
    <tradeName>cobas pro Transport Belt (2 AU, 2 ISE)</tradeName>
    <deviceName>cobas pro Transport Belt</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09205713001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:11.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336179529</udiDi>
    <basicUdiDi>761333601779BN</basicUdiDi>
    <tradeName>cobas pro SBL c 503</tradeName>
    <deviceName>cobas pro SBL c 503</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09205691001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:07.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336179512</udiDi>
    <basicUdiDi>761333601778BL</basicUdiDi>
    <tradeName>cobas pro Transport Line</tradeName>
    <deviceName>cobas pro Transport Line</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09205683001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:07.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336179505</udiDi>
    <basicUdiDi>761333601777BJ</basicUdiDi>
    <tradeName>cobas pro SB</tradeName>
    <deviceName>cobas pro SB</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09205675001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:06.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336179499</udiDi>
    <basicUdiDi>761333601776BG</basicUdiDi>
    <tradeName>cobas pro SSU</tradeName>
    <deviceName>cobas pro SSU</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09205632001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:05.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336172490</udiDi>
    <basicUdiDi>761333601772B8</basicUdiDi>
    <tradeName>sample supply unit</tradeName>
    <deviceName>sample supply unit</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09031537001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:59:54.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630943692</udiDi>
    <basicUdiDi>761333601401A2</basicUdiDi>
    <tradeName>Transport Belt 4 (w/o ISE)</tradeName>
    <deviceName>Transport Belt 4 (w/o ISE)</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05990025001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:06.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630943685</udiDi>
    <basicUdiDi>7613336014009Y</basicUdiDi>
    <tradeName>Transport Belt 3 (w/o ISE)</tradeName>
    <deviceName>Transport Belt 3 (w/o ISE)</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05990017001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:05.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630943678</udiDi>
    <basicUdiDi>761333601399B8</basicUdiDi>
    <tradeName>Transport Belt 2 (w/o ISE)</tradeName>
    <deviceName>Transport Belt 2 (w/o ISE)</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05990009001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:01.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630943661</udiDi>
    <basicUdiDi>761333601398B6</basicUdiDi>
    <tradeName>Transport Belt 1 (w/o ISE)</tradeName>
    <deviceName>Transport Belt 1 (w/o ISE)</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05989990001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:01.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>04015630943616</udiDi>
    <basicUdiDi>761333601377AW</basicUdiDi>
    <tradeName>Transport Belt 4</tradeName>
    <deviceName>Transport Belt 4</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>W02010399</emdnCode>
    <emdnDescription>INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05642116001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:57:00.324Z</lastUpdated>
  </row>
</eudamedExport>