<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936895310440</udiDi>
    <basicUdiDi>B-06936895310440</basicUdiDi>
    <tradeName>Prealbumin (PALB) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Prealbumin (PALB) Test Kit (Immunoturbidimetric)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:16mL×2（791）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:43.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310433</udiDi>
    <basicUdiDi>B-06936895310433</basicUdiDi>
    <tradeName>Prealbumin (PALB) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Prealbumin (PALB) Test Kit (Immunoturbidimetric)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:16mL×2（716）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:43.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310426</udiDi>
    <basicUdiDi>B-06936895310426</basicUdiDi>
    <tradeName>Prealbumin (PALB) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Prealbumin (PALB) Test Kit (Immunoturbidimetric)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:16mL×2（715）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:39.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310419</udiDi>
    <basicUdiDi>B-06936895310419</basicUdiDi>
    <tradeName>Prealbumin (PALB) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Prealbumin (PALB) Test Kit (Immunoturbidimetric)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:40ml×3     R2:20ml×2（704）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:38.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310402</udiDi>
    <basicUdiDi>B-06936895310402</basicUdiDi>
    <tradeName>Prealbumin (PALB) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Prealbumin (PALB) Test Kit (Immunoturbidimetric)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60ml×1     R2:20ml×1（703）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:37.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310396</udiDi>
    <basicUdiDi>B-06936895310396</basicUdiDi>
    <tradeName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</tradeName>
    <deviceName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:20mL×4（796）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:36.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310389</udiDi>
    <basicUdiDi>B-06936895310389</basicUdiDi>
    <tradeName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</tradeName>
    <deviceName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:20mL×4（710）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:32.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310372</udiDi>
    <basicUdiDi>B-06936895310372</basicUdiDi>
    <tradeName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</tradeName>
    <deviceName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:20mL×4（707）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:31.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310365</udiDi>
    <basicUdiDi>B-06936895310365</basicUdiDi>
    <tradeName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</tradeName>
    <deviceName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:100ml×1  R2:100ml×1（708）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:31.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310358</udiDi>
    <basicUdiDi>B-06936895310358</basicUdiDi>
    <tradeName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</tradeName>
    <deviceName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:70mL×4   R2:70mL×4（795）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:29.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310341</udiDi>
    <basicUdiDi>B-06936895310341</basicUdiDi>
    <tradeName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</tradeName>
    <deviceName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50mL×1  R2:50mL×1（794）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:25.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310334</udiDi>
    <basicUdiDi>B-06936895310334</basicUdiDi>
    <tradeName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</tradeName>
    <deviceName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50mL×1  R2:50mL×1（793）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:24.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310327</udiDi>
    <basicUdiDi>B-06936895310327</basicUdiDi>
    <tradeName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</tradeName>
    <deviceName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50mL×1  R2:50mL×1（792）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:47:23.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310310</udiDi>
    <basicUdiDi>B-06936895310310</basicUdiDi>
    <tradeName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</tradeName>
    <deviceName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20ml×2     R2:20ml×2（798）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:45:00.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310303</udiDi>
    <basicUdiDi>B-06936895310303</basicUdiDi>
    <tradeName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</tradeName>
    <deviceName>C Reactive Protein (CRP) Test Kit (Latex Immunoturbidimetric)</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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20ml×2     R2:20ml×2（791）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:44:59.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921893001506</udiDi>
    <basicUdiDi>B-06921893001506</basicUdiDi>
    <tradeName>Cystatin C (Cys-C) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Cystatin C (Cys-C) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Nanjing Norman Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024233</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22400610500050</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:43:56.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921893001490</udiDi>
    <basicUdiDi>B-06921893001490</basicUdiDi>
    <tradeName>Cardiac Troponin I (cTnI) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Cardiac Troponin I (cTnI) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Nanjing Norman Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024233</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22401710500140</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:43:55.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921893001483</udiDi>
    <basicUdiDi>B-06921893001483</basicUdiDi>
    <tradeName>Myocardial Infarction (MI) 3-in-1 (cTnI/CK-MB/MYO) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Myocardial Infarction (MI) 3-in-1 (cTnI/CK-MB/MYO) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Nanjing Norman Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024233</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22401910500020</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:43:51.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921893001476</udiDi>
    <basicUdiDi>B-06921893001476</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Immunofluorescence)</tradeName>
    <deviceName>D-Dimer Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Nanjing Norman Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024233</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22400810500080</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:43:50.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921893001469</udiDi>
    <basicUdiDi>B-06921893001469</basicUdiDi>
    <tradeName>N-terminal pro B-type natriuretic peptide (NT-proBNP) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>N-terminal pro B-type natriuretic peptide (NT-proBNP) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Nanjing Norman Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024233</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22400310500080</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:43:50.114Z</lastUpdated>
  </row>
</eudamedExport>