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<eudamedExport entity="devices">
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    <basicUdiDi>0405686901046V2</basicUdiDi>
    <tradeName>Emit Amikacin Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_KIT_Amikacin Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080301</emdnCode>
    <emdnDescription>AMIKACIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445383</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:07.590Z</lastUpdated>
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  <row>
    <udiDi>00842768001086</udiDi>
    <basicUdiDi>0405686901118V2</basicUdiDi>
    <tradeName>Emit 2000 Gentamicin Plus Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Gentamicin Plus Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445333</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:43.520Z</lastUpdated>
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  <row>
    <udiDi>00630414596020</udiDi>
    <basicUdiDi>0405686901903VV</basicUdiDi>
    <tradeName>Atellica CH Vancomycin (Vanc)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_VANC_2</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>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097511</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:54.020Z</lastUpdated>
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  <row>
    <udiDi>00630414595962</udiDi>
    <basicUdiDi>0405686901778WJ</basicUdiDi>
    <tradeName>Atellica CH Tobramycin (Tob)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_TOB</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>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097517</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:47.619Z</lastUpdated>
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  <row>
    <udiDi>00842768023316</udiDi>
    <basicUdiDi>0405686901118V2</basicUdiDi>
    <tradeName>Emit® 2000 Gentamicin Plus Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Gentamicin Plus Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445335</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:13.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005381</udiDi>
    <basicUdiDi>0405686901202UQ</basicUdiDi>
    <tradeName>Dimension Tobramycin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_TOBR</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444928</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:54.523Z</lastUpdated>
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  <row>
    <udiDi>00842768001109</udiDi>
    <basicUdiDi>0405686901221UU</basicUdiDi>
    <tradeName>Emit 2000 Vancomycin Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Vancomycin Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445336</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:59.226Z</lastUpdated>
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  <row>
    <udiDi>00842768001062</udiDi>
    <basicUdiDi>0405686901203US</basicUdiDi>
    <tradeName>Emit 2000 Tobramycin Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Tobramycin Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445330</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:56.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS9700CW</udiDi>
    <basicUdiDi>B-MS9700CW</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Add-on Set for Antibiotics in Serum / Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS9700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:39.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MFG030062QU</udiDi>
    <basicUdiDi>B-MFG030062QU</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>ALC-MS/MS Kit for the quantitative measurement of antibiotics in serum</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030062</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:06:52.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-474824RA</udiDi>
    <basicUdiDi>B-474824RA</basicUdiDi>
    <tradeName>Vancomycin Reagent (VANC 2 x 100)</tradeName>
    <deviceName>Vancomycin Reagent (VANC 2 x 100)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>474824</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:04:27.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-469137R8</udiDi>
    <basicUdiDi>B-469137R8</basicUdiDi>
    <tradeName>Gentamicin Reagent (GEN 2 x 100)</tradeName>
    <deviceName>Gentamicin Reagent (GEN 2 x 100)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>469137</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:18.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467983S9</udiDi>
    <basicUdiDi>B-467983S9</basicUdiDi>
    <tradeName>Tobramycin Reagent (TOB 2 x 100)</tradeName>
    <deviceName>Tobramycin Reagent (TOB 2 x 100)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467983</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:36.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4300PABXJP</udiDi>
    <basicUdiDi>B-4300PABXJP</basicUdiDi>
    <tradeName>Antibiotics Reagent Set</tradeName>
    <deviceName>Antibiotics Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4300 P ABX</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:44:33.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250438</udiDi>
    <basicUdiDi>B-08683548250438</basicUdiDi>
    <tradeName>RapidFor™ Vancomycin Rapid Test Kit (FIA)</tradeName>
    <deviceName>Vancomycin Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:10:01.016Z</lastUpdated>
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  <row>
    <udiDi>07613336190807</udiDi>
    <basicUdiDi>B-07613336190807</basicUdiDi>
    <tradeName>07613336190807</tradeName>
    <deviceName>CEDIA Gentamicin II Assay (100 tests)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09026924190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:49:04.625Z</lastUpdated>
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    <udiDi>07613336190753</udiDi>
    <basicUdiDi>B-07613336190753</basicUdiDi>
    <tradeName>07613336190753</tradeName>
    <deviceName>CEDIA Gentamicin II Assay (125 tests)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09086137190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:49:02.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753476086</udiDi>
    <basicUdiDi>B-06976753476086</basicUdiDi>
    <tradeName>Human Monkeypox Virus (MPV) IgGIgM Antibody Rapid Test Device（Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A060501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:54.897Z</lastUpdated>
  </row>
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    <udiDi>06976753476055</udiDi>
    <basicUdiDi>B-06976753476055</basicUdiDi>
    <tradeName>Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A051601D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:50.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753472958</udiDi>
    <basicUdiDi>B-06976753472958</basicUdiDi>
    <tradeName>SARS-Cov-2＆ FLU A&amp;B &amp; RSV &amp; Adv Combo Rapid Test Cassett(swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A141301D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:18.509Z</lastUpdated>
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