<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936895301998</udiDi>
    <basicUdiDi>B-06936895301998</basicUdiDi>
    <tradeName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</tradeName>
    <deviceName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibrator L:5mL×1（400126）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:30:40.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895301981</udiDi>
    <basicUdiDi>B-06936895301981</basicUdiDi>
    <tradeName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</tradeName>
    <deviceName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibrator H:5mL×1（400125）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:30:36.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895301974</udiDi>
    <basicUdiDi>B-06936895301974</basicUdiDi>
    <tradeName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</tradeName>
    <deviceName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Internal standard solution:2000mL×1（400124）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:30:36.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895301967</udiDi>
    <basicUdiDi>B-06936895301967</basicUdiDi>
    <tradeName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</tradeName>
    <deviceName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Diluent:2000mL×1（400123）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:30:35.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895301875</udiDi>
    <basicUdiDi>B-06936895301875</basicUdiDi>
    <tradeName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</tradeName>
    <deviceName>Sodium, Potassium and Chlorine Electrolyte Test Kit  (Ion Selective Electrode Method)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Reference solution: 500mL×1（400122）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:30:34.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VPH-502aHG7E</udiDi>
    <basicUdiDi>B-VPH-502aHG7E</basicUdiDi>
    <tradeName>Vaginal pH Rapid Test Cassette (Vaginal Secretions)</tradeName>
    <deviceName>Vaginal pH Rapid Test Cassette (Vaginal Secretions)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VPH-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:26:40.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VPH-501aHG77</udiDi>
    <basicUdiDi>B-VPH-501aHG77</basicUdiDi>
    <tradeName>Vaginal pH Rapid Test Strip (Swab)</tradeName>
    <deviceName>Vaginal pH Rapid Test Strip (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VPH-501a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:26:36.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS50000Q4</udiDi>
    <basicUdiDi>B-MS50000Q4</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Complete Kit for Trace Elements in Plasma / Serum</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS50000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:15:43.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS14000PL</udiDi>
    <basicUdiDi>B-MS14000PL</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Complete Kit for Amino Acids in Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS14000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:14:37.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS10000NQ</udiDi>
    <basicUdiDi>B-MS10000NQ</basicUdiDi>
    <tradeName>ClinSpot®</tradeName>
    <deviceName>ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010402</emdnCode>
    <emdnDescription>MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS10000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:14:19.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IT-MF-000013917BE</udiDi>
    <basicUdiDi>B-IT-MF-000013917BE</basicUdiDi>
    <tradeName>FloMass Lysosomal Storage Diseases in Serum/Plasma</tradeName>
    <deviceName>FloMass Malattie da Accumulo Lisosomiale  in Siero/Plasma</deviceName>
    <manufacturerName>B.S.N. Biological Sales Network S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000013917</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUM26100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:43:04.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HEPATOMIRRL</udiDi>
    <basicUdiDi>B-HEPATOMIRRL</basicUdiDi>
    <tradeName>hepatomiR kit</tradeName>
    <deviceName>hepatomiR kit</deviceName>
    <manufacturerName>TAmiRNA GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000028544</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-031-HEP</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:53:45.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A018D2</udiDi>
    <basicUdiDi>B-A018D2</basicUdiDi>
    <tradeName>INDICAID™ Multiple Urine Test Strip</tradeName>
    <deviceName>INDICAID™ Multiple Urine Test Strip</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Multiple Urine Test Strip</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:24.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77961KD</udiDi>
    <basicUdiDi>B-77961KD</basicUdiDi>
    <tradeName>SPOTCHEM D Total-B</tradeName>
    <deviceName>SPOTCHEM D Total-B</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77961</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:15.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77957KN</udiDi>
    <basicUdiDi>B-77957KN</basicUdiDi>
    <tradeName>SPOTCHEM D Liver</tradeName>
    <deviceName>SPOTCHEM D Liver</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77957</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:14.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77421J8</udiDi>
    <basicUdiDi>B-77421J8</basicUdiDi>
    <tradeName>SPOTCHEM II Heart-2</tradeName>
    <deviceName>SPOTCHEM II Heart-2</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77421</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:53.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77420J6</udiDi>
    <basicUdiDi>B-77420J6</basicUdiDi>
    <tradeName>SPOTCHEM II PANEL-2</tradeName>
    <deviceName>SPOTCHEM II PANEL-2</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77420</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:52.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77423JC</udiDi>
    <basicUdiDi>B-77423JC</basicUdiDi>
    <tradeName>SPOTCHEM II PANEL-V</tradeName>
    <deviceName>SPOTCHEM II PANEL-V</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77423</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:51.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77422JA</udiDi>
    <basicUdiDi>B-77422JA</basicUdiDi>
    <tradeName>SPOTCHEM II Kidney-2</tradeName>
    <deviceName>SPOTCHEM II Kidney-2</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:50.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77419JM</udiDi>
    <basicUdiDi>B-77419JM</basicUdiDi>
    <tradeName>SPOTCHEM II PANEL-1</tradeName>
    <deviceName>SPOTCHEM II PANEL-1</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77419</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:33.731Z</lastUpdated>
  </row>
</eudamedExport>