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    <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>
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    <udiDi>06978945081252</udiDi>
    <basicUdiDi>B-06978945081252</basicUdiDi>
    <tradeName>Methotrexate Control</tradeName>
    <deviceName>Methotrexate Control</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080501</emdnCode>
    <emdnDescription>METHOTREXATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LBZK913A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:19.249Z</lastUpdated>
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    <udiDi>06978945081245</udiDi>
    <basicUdiDi>B-06978945081245</basicUdiDi>
    <tradeName>Methotrexate Kit(LC-MS/MS)</tradeName>
    <deviceName>Methotrexate Kit(LC-MS/MS)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080501</emdnCode>
    <emdnDescription>METHOTREXATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAZP912A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:15.227Z</lastUpdated>
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    <udiDi>06978945081221</udiDi>
    <basicUdiDi>B-06978945081221</basicUdiDi>
    <tradeName>Voriconazole Kit(LC-MS/MS)</tradeName>
    <deviceName>Voriconazole Kit(LC-MS/MS)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAZP908A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:13.815Z</lastUpdated>
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    <udiDi>06978945081207</udiDi>
    <basicUdiDi>B-06978945081207</basicUdiDi>
    <tradeName>Valproic Acid and Carbamazepine Control</tradeName>
    <deviceName>Valproic Acid and Carbamazepine Control</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080299</emdnCode>
    <emdnDescription>CENTRAL NERVOUS SYSTEM TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LBZK905A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:08.005Z</lastUpdated>
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    <udiDi>06978945081191</udiDi>
    <basicUdiDi>B-06978945081191</basicUdiDi>
    <tradeName>Clozapine/Aripiprazole/Risperidone/ Olanzapine Kit(LC-MS/MS)</tradeName>
    <deviceName>Clozapine/Aripiprazole/Risperidone/ Olanzapine Kit(LC-MS/MS)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAZP910A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:07.218Z</lastUpdated>
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    <udiDi>06978945081184</udiDi>
    <basicUdiDi>B-06978945081184</basicUdiDi>
    <tradeName>Valproic Acid and Carbamazepine Kit(LC-MS/MS)</tradeName>
    <deviceName>Valproic Acid and Carbamazepine Kit(LC-MS/MS)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080299</emdnCode>
    <emdnDescription>CENTRAL NERVOUS SYSTEM TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAZP905A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:06.420Z</lastUpdated>
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    <udiDi>06978945081153</udiDi>
    <basicUdiDi>B-06978945081153</basicUdiDi>
    <tradeName>Three Immune Inhibitors Kit(LC-MS/MS)</tradeName>
    <deviceName>Three Immune Inhibitors Kit(LC-MS/MS)</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080699</emdnCode>
    <emdnDescription>IMMUNOSUPPRESSANT TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAZK902A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:57:00.791Z</lastUpdated>
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    <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>
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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>
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    <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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    <udiDi>06976753472651</udiDi>
    <basicUdiDi>B-06976753472651</basicUdiDi>
    <tradeName>Respiratory Syncytial Viral Rapid Test Device  (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>A081301D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:04.115Z</lastUpdated>
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    <udiDi>06974969983022</udiDi>
    <basicUdiDi>B-06974969983022</basicUdiDi>
    <tradeName>Digoxin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Digoxin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200 Tests/kit（DR1159-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:17:32.822Z</lastUpdated>
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    <udiDi>06974969983015</udiDi>
    <basicUdiDi>B-06974969983015</basicUdiDi>
    <tradeName>Digoxin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Digoxin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/kit（DR1159-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:17:31.231Z</lastUpdated>
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    <udiDi>06974969983008</udiDi>
    <basicUdiDi>B-06974969983008</basicUdiDi>
    <tradeName>Digoxin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Digoxin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/kit（DR1159-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:17:28.818Z</lastUpdated>
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    <udiDi>04050598006164</udiDi>
    <basicUdiDi>B-04050598006164</basicUdiDi>
    <tradeName>IDKmonitor® Infliximab drug level</tradeName>
    <deviceName>IDKmonitor® Infliximab drug level</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9655.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:17.951Z</lastUpdated>
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    <udiDi>04050598006157</udiDi>
    <basicUdiDi>B-04050598006157</basicUdiDi>
    <tradeName>IDKmonitor® Adalimumab drug level ELISA</tradeName>
    <deviceName>IDKmonitor® Adalimumab drug level ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9657.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:13.152Z</lastUpdated>
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    <udiDi>04050598005846</udiDi>
    <basicUdiDi>B-04050598005846</basicUdiDi>
    <tradeName>IDKmonitor® Infliximab total ADA</tradeName>
    <deviceName>IDKmonitor® Infliximab total ADA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080701</emdnCode>
    <emdnDescription>INFLIXIMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9654.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:24.200Z</lastUpdated>
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    <udiDi>04050598005839</udiDi>
    <basicUdiDi>B-04050598005839</basicUdiDi>
    <tradeName>IDKmonitor® Adalimumab total ADA ELISA</tradeName>
    <deviceName>IDKmonitor® Adalimumab total ADA ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080702</emdnCode>
    <emdnDescription>ADALIMUMAB</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 9651.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:44:22.581Z</lastUpdated>
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