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<eudamedExport entity="devices">
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    <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>
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    <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>
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    <udiDi>00811403011773</udiDi>
    <basicUdiDi>081140301BT6620942DT6</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-6620942D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:01:31.276Z</lastUpdated>
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    <udiDi>00811403011742</udiDi>
    <basicUdiDi>081140301BT6620941AD6W</basicUdiDi>
    <tradeName>Reference solution</tradeName>
    <deviceName>ISE Reference 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-6620941AD</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:01:30.724Z</lastUpdated>
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  <row>
    <udiDi>00811403011759</udiDi>
    <basicUdiDi>081140301BT6620941DT3</basicUdiDi>
    <tradeName>Reference solution kit</tradeName>
    <deviceName>ISE Reference Solution Kit</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-6620941D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:01:30.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403010486</udiDi>
    <basicUdiDi>081140301AVBP5186D63</basicUdiDi>
    <tradeName>Fluid pack</tradeName>
    <deviceName>Fluid Pack</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>AV-BP5186D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:41.585Z</lastUpdated>
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    <udiDi>00811403010462</udiDi>
    <basicUdiDi>081140301AVBP5032D4P</basicUdiDi>
    <tradeName>Fluid pack</tradeName>
    <deviceName>Fluid Pack</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>AV-BP5032D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:39.171Z</lastUpdated>
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    <udiDi>00811403010417</udiDi>
    <basicUdiDi>081140301AVBP5016D4R</basicUdiDi>
    <tradeName>Fluid pack</tradeName>
    <deviceName>Fluid Pack</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>AV-BP5016D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:33.094Z</lastUpdated>
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  <row>
    <udiDi>00811403010363</udiDi>
    <basicUdiDi>081140301DD61012D7X</basicUdiDi>
    <tradeName>Fluid pack</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-61012D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:11.926Z</lastUpdated>
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  <row>
    <udiDi>00811403010349</udiDi>
    <basicUdiDi>081140301CD473496ADKB</basicUdiDi>
    <tradeName>Buffer pack</tradeName>
    <deviceName>PACK, BUFFER, CHIRON 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-473496AD</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:07.893Z</lastUpdated>
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  <row>
    <udiDi>00811403010332</udiDi>
    <basicUdiDi>081140301CD4787014DJH</basicUdiDi>
    <tradeName>Fluid pack</tradeName>
    <deviceName>CONDITONER, FLUIDS PACK</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-478701-4D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:06.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811403010318</udiDi>
    <basicUdiDi>081140301CD104227ADC6</basicUdiDi>
    <tradeName>Calibration solution</tradeName>
    <deviceName>348 Cal-Pack</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-104227AD</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:00:04.495Z</lastUpdated>
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    <udiDi>00811403010172</udiDi>
    <basicUdiDi>081140301AVBP0442D3Z</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>Standard B AW</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>AV-BP0442D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:59:53.483Z</lastUpdated>
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    <udiDi>00811403010141</udiDi>
    <basicUdiDi>081140301AVBP0380D48</basicUdiDi>
    <tradeName>Conditioning solution</tradeName>
    <deviceName>Electrode Conditioning 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>AV-BP0380D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:59:51.144Z</lastUpdated>
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    <udiDi>00811403010035</udiDi>
    <basicUdiDi>081140301AVBP0095D47</basicUdiDi>
    <tradeName>Reference solution</tradeName>
    <deviceName>Reference Solution AW</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>AV-BP0095D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:59:35.963Z</lastUpdated>
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    <udiDi>00630414636672</udiDi>
    <basicUdiDi>0405686902246VK</basicUdiDi>
    <tradeName>Atellica CH Protein 1 Calibrator (PROT1 CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_PROT 1 CAL</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:35.533Z</lastUpdated>
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    <udiDi>00630414615097</udiDi>
    <basicUdiDi>0405686902241V9</basicUdiDi>
    <tradeName>Atellica CH Bilirubin Calibrator (BILI CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_BILI CAL</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537243</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:44.748Z</lastUpdated>
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    <udiDi>00630414597492</udiDi>
    <basicUdiDi>0405686901837W9</basicUdiDi>
    <tradeName>Atellica CH Chemistry Calibrator (CHEM CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Chemistry Calibrator</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:47.849Z</lastUpdated>
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    <udiDi>00630414597225</udiDi>
    <basicUdiDi>0405686901704VM</basicUdiDi>
    <tradeName>Atellica CH ENZ 1 Calibrator (ENZ 1 CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ENZ 1 CAL</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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099317</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:44.351Z</lastUpdated>
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    <udiDi>00630414597249</udiDi>
    <basicUdiDi>0405686901706VR</basicUdiDi>
    <tradeName>Atellica CH ENZ 3 Calibrator (ENZ 3 CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_ENZ 3 CAL</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11099319</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:44.097Z</lastUpdated>
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