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    <basicUdiDi>B-69328692FI001MCGK</basicUdiDi>
    <tradeName>Prostatic Exosomal Protein Quantitative Detection Kit (Fluorescence lmmunochromatography)</tradeName>
    <deviceName>Prostatic Exosomal Protein Quantitative Detection Kit (Fluorescence lmmunochromatography)</deviceName>
    <manufacturerName>Onco Biomedical Technology (Suzhou) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047590</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSEP-1030001T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:30.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69328692CG001KVF6</udiDi>
    <basicUdiDi>B-69328692CG001KVF6</basicUdiDi>
    <tradeName>Prostatic Exosomal Protein Qualitative Detection Kit (Colloidal Gold)</tradeName>
    <deviceName>Prostatic Exosomal Protein Qualitative Detection Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Onco Biomedical Technology (Suzhou) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047590</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSEP-1030001T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:29.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325008113</udiDi>
    <basicUdiDi>B-04049325008113</basicUdiDi>
    <tradeName>IRT Neonatal Luminescence Immunoassay</tradeName>
    <deviceName>IRT Neonatal Luminescence Immunoassay</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE68015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:11:00.687Z</lastUpdated>
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  <row>
    <udiDi>04049325007666</udiDi>
    <basicUdiDi>B-04049325007666</basicUdiDi>
    <tradeName>IRT Neonatal Luminescence Immunoassay</tradeName>
    <deviceName>IRT Neonatal Luminescence Immunoassay</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE68019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:10:55.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>16932869200110</udiDi>
    <basicUdiDi>69328692DA001JW</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName>Dry Fluorescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Onco Biomedical Technology (Suzhou) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047590</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-Q100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:55:57.519Z</lastUpdated>
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  <row>
    <udiDi>06438147320516</udiDi>
    <basicUdiDi>B-06438147320516</basicUdiDi>
    <tradeName>GSP Neonatal IRT kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3306-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:35:50.327Z</lastUpdated>
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  <row>
    <udiDi>06438147299553</udiDi>
    <basicUdiDi>B-06438147299553</basicUdiDi>
    <tradeName>DELFIA Neonatal IRT kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A005-204</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:35:37.122Z</lastUpdated>
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  <row>
    <udiDi>06438147299515</udiDi>
    <basicUdiDi>B-06438147299515</basicUdiDi>
    <tradeName>DELFIA Neonatal IRT kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A005-210</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:35:35.921Z</lastUpdated>
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    <udiDi>06438147298716</udiDi>
    <basicUdiDi>B-06438147298716</basicUdiDi>
    <tradeName>AutoDELFIA Neonatal IRT kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019007</emdnCode>
    <emdnDescription>IMMUNO REACTIVE TRYPSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B005-212</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:35:34.727Z</lastUpdated>
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