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    <basicUdiDi>B-06942609200037</basicUdiDi>
    <tradeName>ALD CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAD78K2N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T17:13:03.782Z</lastUpdated>
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    <udiDi>06942609202697</udiDi>
    <basicUdiDi>B-06942609202697</basicUdiDi>
    <tradeName>ALD CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAD78K3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T17:13:03.744Z</lastUpdated>
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    <udiDi>06942609200020</udiDi>
    <basicUdiDi>B-06942609200020</basicUdiDi>
    <tradeName>ALD CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAD78K3N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T17:13:03.678Z</lastUpdated>
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    <udiDi>06942609202680</udiDi>
    <basicUdiDi>B-06942609202680</basicUdiDi>
    <tradeName>ALD CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAD78K5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T17:13:03.655Z</lastUpdated>
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    <udiDi>06942609200013</udiDi>
    <basicUdiDi>B-06942609200013</basicUdiDi>
    <tradeName>ALD CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAD78K5N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:53:48.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609205315</udiDi>
    <basicUdiDi>B-06942609205315</basicUdiDi>
    <tradeName>AMH CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHAH06K2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:53:48.345Z</lastUpdated>
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    <udiDi>06942609202628</udiDi>
    <basicUdiDi>B-06942609202628</basicUdiDi>
    <tradeName>AMH CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHAH06K2N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:53:48.289Z</lastUpdated>
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    <udiDi>06942609205308</udiDi>
    <basicUdiDi>B-06942609205308</basicUdiDi>
    <tradeName>AMH CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHAH06K3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:52:42.887Z</lastUpdated>
  </row>
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    <udiDi>06942609202611</udiDi>
    <basicUdiDi>B-06942609202611</basicUdiDi>
    <tradeName>AMH CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHAH06K3N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:52:42.820Z</lastUpdated>
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    <udiDi>06942609205292</udiDi>
    <basicUdiDi>B-06942609205292</basicUdiDi>
    <tradeName>AMH CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHAH06K5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:52:42.774Z</lastUpdated>
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    <udiDi>06942609202604</udiDi>
    <basicUdiDi>B-06942609202604</basicUdiDi>
    <tradeName>AMH CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHAH06K5N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:52:42.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609203311</udiDi>
    <basicUdiDi>B-06942609203311</basicUdiDi>
    <tradeName>Anti-CCP CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP62K2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:52:42.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200624</udiDi>
    <basicUdiDi>B-06942609200624</basicUdiDi>
    <tradeName>Anti-CCP CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP62K2N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:52:42.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609203304</udiDi>
    <basicUdiDi>B-06942609203304</basicUdiDi>
    <tradeName>Anti-CCP CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP62K3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:51:38.610Z</lastUpdated>
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  <row>
    <udiDi>06942609200617</udiDi>
    <basicUdiDi>B-06942609200617</basicUdiDi>
    <tradeName>Anti-CCP CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP62K3N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:51:38.523Z</lastUpdated>
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  <row>
    <udiDi>06942609203298</udiDi>
    <basicUdiDi>B-06942609203298</basicUdiDi>
    <tradeName>Anti-CCP CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP62K5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:51:38.450Z</lastUpdated>
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  <row>
    <udiDi>06942609200600</udiDi>
    <basicUdiDi>B-06942609200600</basicUdiDi>
    <tradeName>Anti-CCP CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCP62K5N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:51:38.393Z</lastUpdated>
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    <udiDi>06942609200167</udiDi>
    <basicUdiDi>B-06942609200167</basicUdiDi>
    <tradeName>BNP CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBN14K0N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:51:38.280Z</lastUpdated>
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    <udiDi>06942609202987</udiDi>
    <basicUdiDi>B-06942609202987</basicUdiDi>
    <tradeName>CA19-9 CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCA28K2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:51:38.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942609200310</udiDi>
    <basicUdiDi>B-06942609200310</basicUdiDi>
    <tradeName>CA19-9 CLIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou KOFA Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045346</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCA28K2N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T16:51:38.128Z</lastUpdated>
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