<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-SAD2022002EM</udiDi>
    <basicUdiDi>B-SAD2022002EM</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Reagent Strips for Urinalysis</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAD2022002</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:36:01.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAD2022001EK</udiDi>
    <basicUdiDi>B-SAD2022001EK</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Reagent Strips for Urinalysis</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAD2022001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:36:00.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K01003-14WH</udiDi>
    <basicUdiDi>B-K01003-14WH</basicUdiDi>
    <tradeName>Urinalysis Reagent Strips (Spectroscopy)</tradeName>
    <deviceName>Urinalysis Reagent Strips (Spectroscopy)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:35:46.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K01003-11WB</udiDi>
    <basicUdiDi>B-K01003-11WB</basicUdiDi>
    <tradeName>Urinalysis Reagent Strips (Spectroscopy)</tradeName>
    <deviceName>Urinalysis Reagent Strips (Spectroscopy)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:35:45.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5193008Q3</udiDi>
    <basicUdiDi>B-HU5193008Q3</basicUdiDi>
    <tradeName>D-HU5193008Q3</tradeName>
    <deviceName>Urinalysis Specific Gravity Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5193008</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:38.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5193002PP</udiDi>
    <basicUdiDi>B-HU5193002PP</basicUdiDi>
    <tradeName>D-HU5193002PP</tradeName>
    <deviceName>Urine Analysis Color Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5193002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:37.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5192008PU</udiDi>
    <basicUdiDi>B-HU5192008PU</basicUdiDi>
    <tradeName>D-HU5192008PU</tradeName>
    <deviceName>Urinalysis Specific Gravity Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5192008</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:32.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5192004PL</udiDi>
    <basicUdiDi>B-HU5192004PL</basicUdiDi>
    <tradeName>D-HU5192004PL</tradeName>
    <deviceName>Urinalysis Sediment Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5192004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:31.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5192003PJ</udiDi>
    <basicUdiDi>B-HU5192003PJ</basicUdiDi>
    <tradeName>D-HU5192003PJ</tradeName>
    <deviceName>Urinalysis Turbidity Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5192003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:30.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5192002PG</udiDi>
    <basicUdiDi>B-HU5192002PG</basicUdiDi>
    <tradeName>D-HU5192002PG</tradeName>
    <deviceName>Urine Analysis Color Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5192002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:26.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5191008PM</udiDi>
    <basicUdiDi>B-HU5191008PM</basicUdiDi>
    <tradeName>D-HU5191008PM</tradeName>
    <deviceName>Urinalysis Specific Gravity Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5191008</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:25.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5191005PF</udiDi>
    <basicUdiDi>B-HU5191005PF</basicUdiDi>
    <tradeName>D-HU5191005PF</tradeName>
    <deviceName>Urinalysis Sediment Focus Fluid</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5191005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:24.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5191004PD</udiDi>
    <basicUdiDi>B-HU5191004PD</basicUdiDi>
    <tradeName>D-HU5191004PD</tradeName>
    <deviceName>Urinalysis Sediment Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5191004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:21.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5191003PB</udiDi>
    <basicUdiDi>B-HU5191003PB</basicUdiDi>
    <tradeName>D-HU5191003PB</tradeName>
    <deviceName>Urinalysis Turbidity Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5191003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:20.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5191002P9</udiDi>
    <basicUdiDi>B-HU5191002P9</basicUdiDi>
    <tradeName>D-HU5191002P9</tradeName>
    <deviceName>Urine Analysis Color Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5191002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:19.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5181004P2</udiDi>
    <basicUdiDi>B-HU5181004P2</basicUdiDi>
    <tradeName>D-HU5181004P2</tradeName>
    <deviceName>Urinalysis Sediment Calibrator</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5181004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:14.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5181003NY</udiDi>
    <basicUdiDi>B-HU5181003NY</basicUdiDi>
    <tradeName>D-HU5181003NY</tradeName>
    <deviceName>Urinalysis Turbidity Calibrator</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5181003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:13.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5181001NU</udiDi>
    <basicUdiDi>B-HU5181001NU</basicUdiDi>
    <tradeName>D-HU5181001NU</tradeName>
    <deviceName>Urinalysis Specific Gravity Calibrator</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5181001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:12.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5112002LQ</udiDi>
    <basicUdiDi>B-HU5112002LQ</basicUdiDi>
    <tradeName>D-HU5112002LQ</tradeName>
    <deviceName>Urine Test Strips</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5112002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:11.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HU5109002MW</udiDi>
    <basicUdiDi>B-HU5109002MW</basicUdiDi>
    <tradeName>D-HU5109002MW</tradeName>
    <deviceName>Urine Test Strips</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5109002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:58:56.394Z</lastUpdated>
  </row>
</eudamedExport>