<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00811403014583</udiDi>
    <basicUdiDi>081140301DD6101383</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>Standard B UNITY</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-61013</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:03:27.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403014576</udiDi>
    <basicUdiDi>081140301DD610127Z</basicUdiDi>
    <tradeName>Calibration Solution</tradeName>
    <deviceName>Fluid Pack Unity</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD-61012</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:03:26.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403014194</udiDi>
    <basicUdiDi>081140301DAS625DK9</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>Standard B IMT</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA-S625D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:03:19.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403014187</udiDi>
    <basicUdiDi>081140301DAS620DJS</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>Quicklyte Standard A RXL</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA-S620D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:03:18.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403014040</udiDi>
    <basicUdiDi>081140301DAD105DCP</basicUdiDi>
    <tradeName>Reference solution</tradeName>
    <deviceName>Salt Bridge Solution</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA-D105D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:03:13.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403013180</udiDi>
    <basicUdiDi>081140301CD473496DC7</basicUdiDi>
    <tradeName>Calibration solution</tradeName>
    <deviceName>Buffer Pack 248</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-473496D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:02:59.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403013067</udiDi>
    <basicUdiDi>081140301CD105670ADDX</basicUdiDi>
    <tradeName>Calibration gas</tradeName>
    <deviceName>Slope, HCT, Corning Solution</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-105670AD</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:02:54.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403013036</udiDi>
    <basicUdiDi>081140301CD104227D6N</basicUdiDi>
    <tradeName>Buffer pack</tradeName>
    <deviceName>Buffer Pack 348</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-104227D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:02:49.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403012732</udiDi>
    <basicUdiDi>081140301BM836246DH5</basicUdiDi>
    <tradeName>Reference solution</tradeName>
    <deviceName>ISE Internal Reference Solution HT917 6X2L</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-836246D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:02:47.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403012725</udiDi>
    <basicUdiDi>081140301BM820639DFN</basicUdiDi>
    <tradeName>Electrolyte solution</tradeName>
    <deviceName>KCL Electrolyte Solution H917</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-820639D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:02:47.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403012619</udiDi>
    <basicUdiDi>081140301BM620428DDW</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>ISE Low Standard</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-620428D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:02:14.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403012602</udiDi>
    <basicUdiDi>081140301BM620427DDT</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>ISE High Standard</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-620427D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:02:10.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403012589</udiDi>
    <basicUdiDi>081140301BM450042DCX</basicUdiDi>
    <tradeName>Reference solution</tradeName>
    <deviceName>ISE Internal Reference HT911</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-450042D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:02:10.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403012572</udiDi>
    <basicUdiDi>081140301BM450041DCU</basicUdiDi>
    <tradeName>Electrolyte solution</tradeName>
    <deviceName>KCL Electrolyte Solution, HT911</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-450041D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:02:10.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403012534</udiDi>
    <basicUdiDi>081140301BM1489828DPN</basicUdiDi>
    <tradeName>Calibrator solution</tradeName>
    <deviceName>ISE Compensator</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-1489828D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:02:02.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403011810</udiDi>
    <basicUdiDi>081140301BT6620944DTC</basicUdiDi>
    <tradeName>Calibrator solution</tradeName>
    <deviceName>ISE Calibrator High Kit BT3000</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-6620944D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:01:38.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403011803</udiDi>
    <basicUdiDi>081140301BT6620944AD7D</basicUdiDi>
    <tradeName>Calibrator solution</tradeName>
    <deviceName>ISE Calibrator High BT 3000/3000+</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-6620944AD</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:01:37.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403011797</udiDi>
    <basicUdiDi>081140301BT6620943DT9</basicUdiDi>
    <tradeName>Calibrator solution</tradeName>
    <deviceName>ISE Calibrator Low Kit BT 3000</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-6620943D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:01:36.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403011780</udiDi>
    <basicUdiDi>081140301BT6620943AD78</basicUdiDi>
    <tradeName>ISE calibrator</tradeName>
    <deviceName>ISE Calibrator Low, BT 3000/3000+</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-6620943AD</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:01:36.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403011766</udiDi>
    <basicUdiDi>081140301BT6620942AD73</basicUdiDi>
    <tradeName>Buffer solution</tradeName>
    <deviceName>ISE Buffer Solution, BT 3000</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-6620942AD</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:01:32.065Z</lastUpdated>
  </row>
</eudamedExport>