<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800111724831</udiDi>
    <basicUdiDi>88001117IAAA01PA14L7</basicUdiDi>
    <tradeName>STANDARD™ LMS (Lipid Management Software)</tradeName>
    <deviceName>STANDARD™ LMS (Lipid Management Software)</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02LMS10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:35.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111724824</udiDi>
    <basicUdiDi>88001117IAAA01PA15L9</basicUdiDi>
    <tradeName>STANDARD™ DMS (Diabetes Management Software)</tradeName>
    <deviceName>STANDARD™ DMS (Diabetes Management Software)</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01DMS10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:33.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111724817</udiDi>
    <basicUdiDi>88001117IAAA02PA15LL</basicUdiDi>
    <tradeName>Pic Diabetes Management</tradeName>
    <deviceName>Pic Diabetes Management</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99DMS30</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:32.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111724800</udiDi>
    <basicUdiDi>88001117IAAA01PA16LB</basicUdiDi>
    <tradeName>GlucoNavii® App</tradeName>
    <deviceName>GlucoNavii® App</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01APP10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:31.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336227343</udiDi>
    <basicUdiDi>761333602948BU</basicUdiDi>
    <tradeName>cobas c 513 analyzer System Software Version 02-06</tradeName>
    <deviceName>cobas c 513 analyzer System Software Version 02-06</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10073713001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:10.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336227282</udiDi>
    <basicUdiDi>761333602949BW</basicUdiDi>
    <tradeName>cobas c 513 analyzer Language Pack -Chinese Version 2.6.zh</tradeName>
    <deviceName>cobas c 513 analyzer Language Pack Version 2.6</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10073659001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:09.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336224489</udiDi>
    <basicUdiDi>761333602777BR</basicUdiDi>
    <tradeName>cobas 8000 modular analyzer series System Software Version 06-10</tradeName>
    <deviceName>cobas 8000 modular analyzer series System Software Version 06-10</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09976418001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:03.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336224403</udiDi>
    <basicUdiDi>761333602778BT</basicUdiDi>
    <tradeName>cobas 8000 modular analyzer series Language Pack - German Version 6.10.de</tradeName>
    <deviceName>cobas 8000 modular analyzer series Language Pack - Version 6.10</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09976264001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:02:01.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336218525</udiDi>
    <basicUdiDi>761333602635B4</basicUdiDi>
    <tradeName>cobas pure integrated solutions Language Pack - English Version 1.3.1.en</tradeName>
    <deviceName>cobas pure integrated solutions Language Pack Version 1.3.1</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09756817001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:50.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336218518</udiDi>
    <basicUdiDi>761333602640AV</basicUdiDi>
    <tradeName>cobas pure integrated solutions System Software Version 01-03</tradeName>
    <deviceName>cobas pure integrated solutions System Software Version 01-03</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09756809001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:49.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336217900</udiDi>
    <basicUdiDi>761333602639BC</basicUdiDi>
    <tradeName>cobas pro integrated solutions System Software Version 02-03</tradeName>
    <deviceName>cobas pro integrated solutions System Software Version 02-03</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09719385001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:42.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336215852</udiDi>
    <basicUdiDi>761333602638BA</basicUdiDi>
    <tradeName>cobas 8000 modular analyzer series Language Pack - Chinese Version 6.9.1.zh</tradeName>
    <deviceName>cobas 8000 modular analyzer series Language Pack Version 6.9.1</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09720073001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:01:36.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336188644</udiDi>
    <basicUdiDi>761333601996BY</basicUdiDi>
    <tradeName>cobas c 311 analyzer Instrument Software Version 01-13</tradeName>
    <deviceName>cobas c 311 analyzer Instrument Software Version 01-13</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09465596001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:45.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336188583</udiDi>
    <basicUdiDi>761333601997C2</basicUdiDi>
    <tradeName>cobas c 311 analyzer Language Pack 1.13.1.pt</tradeName>
    <deviceName>cobas c 311 analyzer Language Pack</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09465537001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:44.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336188262</udiDi>
    <basicUdiDi>761333602146AG</basicUdiDi>
    <tradeName>cobas pure integrated solutions Language Pack - German Version 01-02</tradeName>
    <deviceName>cobas pure integrated solutions Language Pack</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09458620001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:43.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336187722</udiDi>
    <basicUdiDi>761333602149AN</basicUdiDi>
    <tradeName>cobas c 513 analyzer System software installation CD Version 02-05</tradeName>
    <deviceName>cobas c 513 analyzer System software installation CD Version 02-05</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09440194001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:39.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336187739</udiDi>
    <basicUdiDi>761333602156AK</basicUdiDi>
    <tradeName>cobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2;5;1</tradeName>
    <deviceName>cobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2;5;1</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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09440208001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:00:37.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336188279</udiDi>
    <basicUdiDi>761333602146AG</basicUdiDi>
    <tradeName>cobas pure integrated solutions Language Pack - French Version 01-02</tradeName>
    <deviceName></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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09458646001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:33:09.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336188286</udiDi>
    <basicUdiDi>761333602146AG</basicUdiDi>
    <tradeName>cobas pure integrated solutions Language Pack - Italian Version 01-02</tradeName>
    <deviceName></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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09458644001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:33:09.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>07613336188293</udiDi>
    <basicUdiDi>761333602146AG</basicUdiDi>
    <tradeName>cobas pure integrated solutions Language Pack - Spanish Version 01-02</tradeName>
    <deviceName></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>W0201010182</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09458697001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:33:09.770Z</lastUpdated>
  </row>
</eudamedExport>