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<eudamedExport entity="devices">
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    <udiDi>D-0320518103WC</udiDi>
    <basicUdiDi>B-0320518103WC</basicUdiDi>
    <tradeName>Digoxin (eCLIA)</tradeName>
    <deviceName>Digoxin (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320518103</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:21.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320518102WA</udiDi>
    <basicUdiDi>B-0320518102WA</basicUdiDi>
    <tradeName>Digoxin (eCLIA)</tradeName>
    <deviceName>Digoxin (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320518102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:21.086Z</lastUpdated>
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  <row>
    <udiDi>D-0320518101W8</udiDi>
    <basicUdiDi>B-0320518101W8</basicUdiDi>
    <tradeName>Digoxin (eCLIA)</tradeName>
    <deviceName>Digoxin (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320518101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:34:19.483Z</lastUpdated>
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  <row>
    <udiDi>00894354002113</udiDi>
    <basicUdiDi>B-00894354002113</basicUdiDi>
    <tradeName>My5-FU Sample Stabilizer Kit</tradeName>
    <deviceName>My5-FU Sample Stabilizer Kit</deviceName>
    <manufacturerName>Saladax Biomedical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007957</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080599</emdnCode>
    <emdnDescription>ANTI-NEOPLASTIC TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5FU-STB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:44.502Z</lastUpdated>
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  <row>
    <udiDi>00884883012837</udiDi>
    <basicUdiDi>B-00884883012837</basicUdiDi>
    <tradeName>00884883012837</tradeName>
    <deviceName>QMS Vancomycin Immunoassay</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>W0102080319</emdnCode>
    <emdnDescription>VANCOMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10017224</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:17.663Z</lastUpdated>
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  <row>
    <udiDi>00884883012714</udiDi>
    <basicUdiDi>B-00884883012714</basicUdiDi>
    <tradeName>00884883012714</tradeName>
    <deviceName>QMS Zonisamide Assay</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>W0102080214</emdnCode>
    <emdnDescription>ZONISAMIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10017230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:15.245Z</lastUpdated>
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  <row>
    <udiDi>00884883012707</udiDi>
    <basicUdiDi>B-00884883012707</basicUdiDi>
    <tradeName>00884883012707</tradeName>
    <deviceName>QMS Topiramate Assay</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>W0102080213</emdnCode>
    <emdnDescription>TOPIRAMATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10017218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:13.643Z</lastUpdated>
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  <row>
    <udiDi>00884883012691</udiDi>
    <basicUdiDi>B-00884883012691</basicUdiDi>
    <tradeName>00884883012691</tradeName>
    <deviceName>QMS Tobramycin Assay</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>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10017109</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:11.252Z</lastUpdated>
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  <row>
    <udiDi>00884883012677</udiDi>
    <basicUdiDi>B-00884883012677</basicUdiDi>
    <tradeName>00884883012677</tradeName>
    <deviceName>QMS Gentamicin Assay</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>10017107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:09.643Z</lastUpdated>
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  <row>
    <udiDi>00884883012660</udiDi>
    <basicUdiDi>B-00884883012660</basicUdiDi>
    <tradeName>00884883012660</tradeName>
    <deviceName>QMS Amikacin Assay</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>W0102080301</emdnCode>
    <emdnDescription>AMIKACIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10017196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:08.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883012622</udiDi>
    <basicUdiDi>B-00884883012622</basicUdiDi>
    <tradeName>00884883012622</tradeName>
    <deviceName>QMS Teico Rgt Kit</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>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374645</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:07.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883012615</udiDi>
    <basicUdiDi>B-00884883012615</basicUdiDi>
    <tradeName>00884883012615</tradeName>
    <deviceName>QMS Teicoplanin Cal Kit</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>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374652</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:04.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883012608</udiDi>
    <basicUdiDi>B-00884883012608</basicUdiDi>
    <tradeName>00884883012608</tradeName>
    <deviceName>QMS Teicoplanin Ctrl Kit</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>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374660</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:03.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883012592</udiDi>
    <basicUdiDi>B-00884883012592</basicUdiDi>
    <tradeName>00884883012592</tradeName>
    <deviceName>QMS Tacrolimus Calibrators</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>W0102080603</emdnCode>
    <emdnDescription>TACROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10015573</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:02.436Z</lastUpdated>
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  <row>
    <udiDi>00884883011878</udiDi>
    <basicUdiDi>B-00884883011878</basicUdiDi>
    <tradeName>00884883011878</tradeName>
    <deviceName>CEDIA Mycophenolic Acid Assay</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>W0102080605</emdnCode>
    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10016265</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:31:22.356Z</lastUpdated>
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  <row>
    <udiDi>00884883011854</udiDi>
    <basicUdiDi>B-00884883011854</basicUdiDi>
    <tradeName>00884883011854</tradeName>
    <deviceName>QMS Everolimus Immunoassay</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>W0102080606</emdnCode>
    <emdnDescription>EVEROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10015987</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:31:19.956Z</lastUpdated>
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  <row>
    <udiDi>00884883011830</udiDi>
    <basicUdiDi>B-00884883011830</basicUdiDi>
    <tradeName>00884883011830</tradeName>
    <deviceName>QMS Tacrolimus Immunoassay</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>W0102080603</emdnCode>
    <emdnDescription>TACROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10015556</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:31:18.357Z</lastUpdated>
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  <row>
    <udiDi>00884883011687</udiDi>
    <basicUdiDi>B-00884883011687</basicUdiDi>
    <tradeName>00884883011687</tradeName>
    <deviceName>QMS Everolimus Reagent</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>W0102080606</emdnCode>
    <emdnDescription>EVEROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0380000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:31:15.950Z</lastUpdated>
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  <row>
    <udiDi>00884883011434</udiDi>
    <basicUdiDi>B-00884883011434</basicUdiDi>
    <tradeName>00884883011434</tradeName>
    <deviceName>DRI Digoxin Assay</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>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1669-A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:26.276Z</lastUpdated>
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  <row>
    <udiDi>00884883011328</udiDi>
    <basicUdiDi>B-00884883011328</basicUdiDi>
    <tradeName>00884883011328</tradeName>
    <deviceName>QMS Tobramycin Calibrators</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>W0102080317</emdnCode>
    <emdnDescription>TOBRAMYCIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:18.272Z</lastUpdated>
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</eudamedExport>