<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06978907680028</udiDi>
    <basicUdiDi>697890768MPS3L</basicUdiDi>
    <tradeName>Medical Polymeric Splint</tradeName>
    <deviceName>Medical Polymeric Splint</deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03050202</emdnCode>
    <emdnDescription>SYNTHETIC CAST BANDAGES AND SPLINTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120x195x2.4</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-09-22T19:32:56.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680011</udiDi>
    <basicUdiDi>697890768ETFDXL</basicUdiDi>
    <tradeName>Endotracheal Tube Fixation Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QGCG-Ⅰ</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:14:29.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680332</udiDi>
    <basicUdiDi>697890768DUSSZP</basicUdiDi>
    <tradeName>06978907680332</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type I·10 mL·1 set/bag</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:26.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680417</udiDi>
    <basicUdiDi>697890768FIAYM</basicUdiDi>
    <tradeName>Fluorescent Immunochromatographic Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S-300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:26.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680257</udiDi>
    <basicUdiDi>697890768DMUCDXZ</basicUdiDi>
    <tradeName>Disposable Midstream Urine Collection Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type I·10 mL·1 set/bag</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:25.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680424</udiDi>
    <basicUdiDi>B-06978907680424</basicUdiDi>
    <tradeName>TSH Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:24.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680431</udiDi>
    <basicUdiDi>B-06978907680431</basicUdiDi>
    <tradeName>NGAL/CysC/β2-MG Combined (FIA) Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:24.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680448</udiDi>
    <basicUdiDi>B-06978907680448</basicUdiDi>
    <tradeName>SAA Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:23.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680455</udiDi>
    <basicUdiDi>B-06978907680455</basicUdiDi>
    <tradeName>FA/VB12/Ferritin Combined (FIA) Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:23.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680462</udiDi>
    <basicUdiDi>B-06978907680462</basicUdiDi>
    <tradeName>NT-proBNP Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:22.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680479</udiDi>
    <basicUdiDi>B-06978907680479</basicUdiDi>
    <tradeName>25-OH-VD (Vitamin D) Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:21.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680486</udiDi>
    <basicUdiDi>B-06978907680486</basicUdiDi>
    <tradeName>Progesterone Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:21.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680493</udiDi>
    <basicUdiDi>B-06978907680493</basicUdiDi>
    <tradeName>Estradiol (E2) Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:20.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680509</udiDi>
    <basicUdiDi>B-06978907680509</basicUdiDi>
    <tradeName>FT4 Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:20.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680516</udiDi>
    <basicUdiDi>B-06978907680516</basicUdiDi>
    <tradeName>cTnI/CK-MB/MYO Cardiac Panel (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:05.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680523</udiDi>
    <basicUdiDi>B-06978907680523</basicUdiDi>
    <tradeName>Procalcitonin (PCT) Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:05.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680530</udiDi>
    <basicUdiDi>B-06978907680530</basicUdiDi>
    <tradeName>Intact Parathyroid Hormone (iPTH) Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:04.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680547</udiDi>
    <basicUdiDi>B-06978907680547</basicUdiDi>
    <tradeName>FT3 Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:04.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680554</udiDi>
    <basicUdiDi>B-06978907680554</basicUdiDi>
    <tradeName>BGP (Osteocalcin) Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:04.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978907680561</udiDi>
    <basicUdiDi>B-06978907680561</basicUdiDi>
    <tradeName>CRP Fluorescent Immunochromatographic Assay (FIA) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hebei Sanxin Pharmaceutical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057708</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>25 tests per box</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T21:41:03.330Z</lastUpdated>
  </row>
</eudamedExport>