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    <udiDi>D-CNMF000049232R3300148VW</udiDi>
    <basicUdiDi>B-CNMF000049232R3300148VW</basicUdiDi>
    <tradeName>Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R33001-048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:50.165Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000049232R3300196W9</udiDi>
    <basicUdiDi>B-CNMF000049232R3300196W9</basicUdiDi>
    <tradeName>Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R33001-096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:50.126Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000049232R3400148WB</udiDi>
    <basicUdiDi>B-CNMF000049232R3400148WB</basicUdiDi>
    <tradeName>Human BCR-ABL(P210) Fusion Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34001-048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:50.078Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000049232R3400196WN</udiDi>
    <basicUdiDi>B-CNMF000049232R3400196WN</basicUdiDi>
    <tradeName>Human BCR-ABL(P210) Fusion Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34001-096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:50.032Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000049232R3400248WG</udiDi>
    <basicUdiDi>B-CNMF000049232R3400248WG</basicUdiDi>
    <tradeName>Human BCR-ABL(P190) Fusion Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34002-048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:49.984Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000049232R3400296WT</udiDi>
    <basicUdiDi>B-CNMF000049232R3400296WT</basicUdiDi>
    <tradeName>Human BCR-ABL(P190) Fusion Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34002-096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:49.936Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000049232R3400448WS</udiDi>
    <basicUdiDi>B-CNMF000049232R3400448WS</basicUdiDi>
    <tradeName>Human AML1-ETO Fusion Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34004-048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:49.892Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000049232R3400496X5</udiDi>
    <basicUdiDi>B-CNMF000049232R3400496X5</basicUdiDi>
    <tradeName>Human AML1-ETO Fusion Gene Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34004-096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:49.847Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000049232R3400848XE</udiDi>
    <basicUdiDi>B-CNMF000049232R3400848XE</basicUdiDi>
    <tradeName>Human HER2 Gene copy number variation Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34008-048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:49.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000049232R3400896XR</udiDi>
    <basicUdiDi>B-CNMF000049232R3400896XR</basicUdiDi>
    <tradeName>Human HER2 Gene copy number variation Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34008-096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:49.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000049232R3401048WD</udiDi>
    <basicUdiDi>B-CNMF000049232R3401048WD</basicUdiDi>
    <tradeName>Human BRAF Gene V600E Mutation Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34010-048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:49.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000049232R3401096WQ</udiDi>
    <basicUdiDi>B-CNMF000049232R3401096WQ</basicUdiDi>
    <tradeName>Human BRAF Gene V600E Mutation Detection Kit (Digital PCR Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34010-096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:49.662Z</lastUpdated>
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