<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974490250426</udiDi>
    <basicUdiDi>B-06974490250426</basicUdiDi>
    <tradeName>Coagulation Control Plasma</tradeName>
    <deviceName>Coagulation Control Plasma</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONP-I-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:05.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250396</udiDi>
    <basicUdiDi>B-06974490250396</basicUdiDi>
    <tradeName>Fibrinogen Reference Plasma</tradeName>
    <deviceName>Fibrinogen Reference Plasma</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STD-FIB-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:04.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974490250365</udiDi>
    <basicUdiDi>B-06974490250365</basicUdiDi>
    <tradeName>Fibrin Degradation Product (FDP) Control</tradeName>
    <deviceName>Fibrin Degradation Product (FDP) Control</deviceName>
    <manufacturerName>SysCan BioTech (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040462</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDPII-01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:40:04.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339211293</udiDi>
    <basicUdiDi>B-06937339211293</basicUdiDi>
    <tradeName>Blood Glucose Control Solution</tradeName>
    <deviceName>Blood Glucose Control Solution</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGC02-0Y1</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:40.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339211286</udiDi>
    <basicUdiDi>B-06937339211286</basicUdiDi>
    <tradeName>Blood Glucose Test Strip</tradeName>
    <deviceName>Blood Glucose Test Strip</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS02-0Y2</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:40.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339211279</udiDi>
    <basicUdiDi>B-06937339211279</basicUdiDi>
    <tradeName>Blood Glucose Test Strip</tradeName>
    <deviceName>Blood Glucose Test Strip</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS02-0Y1</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:39.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339211262</udiDi>
    <basicUdiDi>B-06937339211262</basicUdiDi>
    <tradeName>Blood Glucose Test Strip</tradeName>
    <deviceName>Blood Glucose Test Strip</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS02-0Y3</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:38.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310297</udiDi>
    <basicUdiDi>B-06936895310297</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（716）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:34.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310280</udiDi>
    <basicUdiDi>B-06936895310280</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（715）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:33.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310273</udiDi>
    <basicUdiDi>B-06936895310273</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（704）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:32.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310266</udiDi>
    <basicUdiDi>B-06936895310266</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×1     R2:20ml×1（703）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:32.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310235</udiDi>
    <basicUdiDi>B-06936895310235</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) 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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2    R2:24mL×1（792）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:28.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310228</udiDi>
    <basicUdiDi>B-06936895310228</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) 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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2    R2:24mL×1（791）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:27.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310259</udiDi>
    <basicUdiDi>B-06936895310259</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) 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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:64mL×6   R2:48mL×2（795）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:26.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310242</udiDi>
    <basicUdiDi>B-06936895310242</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) 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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50mL×2    R2:25mL×1（793）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:25.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310211</udiDi>
    <basicUdiDi>B-06936895310211</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) 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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:5mL×4（796）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:08.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310204</udiDi>
    <basicUdiDi>B-06936895310204</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) 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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:5mL×4（710）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:08.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310198</udiDi>
    <basicUdiDi>B-06936895310198</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) 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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:5mL×4（707）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:07.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310181</udiDi>
    <basicUdiDi>B-06936895310181</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) 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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:64mL×2  R2:16mL×2（794）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:06.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895310174</udiDi>
    <basicUdiDi>B-06936895310174</basicUdiDi>
    <tradeName>Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) 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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×2  R2:12mL×2（798）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T03:39:02.491Z</lastUpdated>
  </row>
</eudamedExport>