<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06980370960217</udiDi>
    <basicUdiDi>B-06980370960217</basicUdiDi>
    <tradeName>06980370960217</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:53:02.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960224</udiDi>
    <basicUdiDi>B-06980370960224</basicUdiDi>
    <tradeName>06980370960224</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:53:01.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960231</udiDi>
    <basicUdiDi>B-06980370960231</basicUdiDi>
    <tradeName>06980370960231</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:53:00.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960248</udiDi>
    <basicUdiDi>B-06980370960248</basicUdiDi>
    <tradeName>06980370960248</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:52:22.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960255</udiDi>
    <basicUdiDi>B-06980370960255</basicUdiDi>
    <tradeName>06980370960255</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:52:22.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960262</udiDi>
    <basicUdiDi>B-06980370960262</basicUdiDi>
    <tradeName>06980370960262</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:52:20.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960279</udiDi>
    <basicUdiDi>B-06980370960279</basicUdiDi>
    <tradeName>06980370960279</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:52:20.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960286</udiDi>
    <basicUdiDi>B-06980370960286</basicUdiDi>
    <tradeName>06980370960286</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:52:19.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960293</udiDi>
    <basicUdiDi>B-06980370960293</basicUdiDi>
    <tradeName>06980370960293</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:52:18.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960309</udiDi>
    <basicUdiDi>B-06980370960309</basicUdiDi>
    <tradeName>06980370960309</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:52:18.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960316</udiDi>
    <basicUdiDi>B-06980370960316</basicUdiDi>
    <tradeName>06980370960316</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:52:16.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960323</udiDi>
    <basicUdiDi>B-06980370960323</basicUdiDi>
    <tradeName>06980370960323</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:51:49.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960330</udiDi>
    <basicUdiDi>B-06980370960330</basicUdiDi>
    <tradeName>06980370960330</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:51:49.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960347</udiDi>
    <basicUdiDi>B-06980370960347</basicUdiDi>
    <tradeName>06980370960347</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T02:51:48.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980370960002</udiDi>
    <basicUdiDi>B-06980370960002</basicUdiDi>
    <tradeName>06980370960002</tradeName>
    <deviceName>Amikacin (AMK) Test Kit</deviceName>
    <manufacturerName>Guoyi Medical (Hainan) Pharmaceutical Holdings Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057448</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1test/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-06T20:30:00.964Z</lastUpdated>
  </row>
</eudamedExport>