<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CNMF000054349CR051GL</udiDi>
    <basicUdiDi>B-CNMF000054349CR051GL</basicUdiDi>
    <tradeName>Malaria Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>CR051</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR057b64</udiDi>
    <basicUdiDi>B-CNMF000054349CR057b64</basicUdiDi>
    <tradeName>Strep B Antigen Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STREP. B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR057</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR057GY</udiDi>
    <basicUdiDi>B-CNMF000054349CR057GY</basicUdiDi>
    <tradeName>Malaria pf/pan Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>CR057</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP001G2</udiDi>
    <basicUdiDi>B-CNMF000054349DP001G2</basicUdiDi>
    <tradeName>AMP  Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP002G4</udiDi>
    <basicUdiDi>B-CNMF000054349DP002G4</basicUdiDi>
    <tradeName>MOP Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP003G6</udiDi>
    <basicUdiDi>B-CNMF000054349DP003G6</basicUdiDi>
    <tradeName>MDMA Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP004G8</udiDi>
    <basicUdiDi>B-CNMF000054349DP004G8</basicUdiDi>
    <tradeName>KET Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP005GA</udiDi>
    <basicUdiDi>B-CNMF000054349DP005GA</basicUdiDi>
    <tradeName>MET Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP006GC</udiDi>
    <basicUdiDi>B-CNMF000054349DP006GC</basicUdiDi>
    <tradeName>BAR Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP007GE</udiDi>
    <basicUdiDi>B-CNMF000054349DP007GE</basicUdiDi>
    <tradeName>BZO Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP008GG</udiDi>
    <basicUdiDi>B-CNMF000054349DP008GG</basicUdiDi>
    <tradeName>COC Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP009GJ</udiDi>
    <basicUdiDi>B-CNMF000054349DP009GJ</basicUdiDi>
    <tradeName>THC Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP010G3</udiDi>
    <basicUdiDi>B-CNMF000054349DP010G3</basicUdiDi>
    <tradeName>BAR/BZO/MOP Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP011G5</udiDi>
    <basicUdiDi>B-CNMF000054349DP011G5</basicUdiDi>
    <tradeName>MOP/MET/MDMA Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP012G7</udiDi>
    <basicUdiDi>B-CNMF000054349DP012G7</basicUdiDi>
    <tradeName>MOP/MET/KET/MDMA/THC/COC Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP013G9</udiDi>
    <basicUdiDi>B-CNMF000054349DP013G9</basicUdiDi>
    <tradeName>DP013</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP014GB</udiDi>
    <basicUdiDi>B-CNMF000054349DP014GB</basicUdiDi>
    <tradeName>MTD Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP015GD</udiDi>
    <basicUdiDi>B-CNMF000054349DP015GD</basicUdiDi>
    <tradeName>COT Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP016GF</udiDi>
    <basicUdiDi>B-CNMF000054349DP016GF</basicUdiDi>
    <tradeName>MTHP Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349DP017GH</udiDi>
    <basicUdiDi>B-CNMF000054349DP017GH</basicUdiDi>
    <tradeName>MQL Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</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>DP017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:48.313Z</lastUpdated>
  </row>
</eudamedExport>