<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936895306863</udiDi>
    <basicUdiDi>B-06936895306863</basicUdiDi>
    <tradeName>Rheumatoid Factor (RF) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Rheumatoid Factor (RF) 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:80ml×1     R2:20ml×1（703）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:26:47.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895302988</udiDi>
    <basicUdiDi>B-06936895302988</basicUdiDi>
    <tradeName>Troponin I (TnI) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Troponin I (TnI) Test Kit (Latex Enhanced 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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibrator：1mL×6（91138）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:24:37.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895300427</udiDi>
    <basicUdiDi>B-06936895300427</basicUdiDi>
    <tradeName>Homocysteine (HCY) Test Kit (Enzymatic)</tradeName>
    <deviceName>Homocysteine (HCY) Test Kit (Enzymatic)</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>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:48mL×1  R2:13mL×1（700081）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:19:50.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895300311</udiDi>
    <basicUdiDi>B-06936895300311</basicUdiDi>
    <tradeName>Ferritin (Fet)Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>Ferritin (Fet)Test Kit (Latex Enhanced 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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibrator：1mL×1（91085）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:19:48.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936791020115</udiDi>
    <basicUdiDi>B-06936791020115</basicUdiDi>
    <tradeName>06936791020115</tradeName>
    <deviceName>Quantitative Diagnostic Kit for Procalcitonin (PCT) (Colloidal Gold Method)</deviceName>
    <manufacturerName>Zhongshan Bio-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028828</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JG0301-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:15:10.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936791010024</udiDi>
    <basicUdiDi>B-06936791010024</basicUdiDi>
    <tradeName>06936791010024</tradeName>
    <deviceName>Detection Kit for Alpha Fetoprotein (ELISA)</deviceName>
    <manufacturerName>Zhongshan Bio-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028828</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JT0101-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:14:30.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936791010017</udiDi>
    <basicUdiDi>B-06936791010017</basicUdiDi>
    <tradeName>06936791010017</tradeName>
    <deviceName>Detection Kit for Carcino-embryonic Antigen (ELISA)</deviceName>
    <manufacturerName>Zhongshan Bio-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028828</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP0101-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:14:27.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175046270</udiDi>
    <basicUdiDi>B-06934175046270</basicUdiDi>
    <tradeName>C-Reactive Protein</tradeName>
    <deviceName>C-reactive Protein Quantitative Test Kit (Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12600783</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:08:00.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175009442</udiDi>
    <basicUdiDi>B-06934175009442</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName>Neutrophil gelatinase-associated lipocalin Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>12600551</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:07:28.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175009435</udiDi>
    <basicUdiDi>B-06934175009435</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>12600550</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:07:26.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175009428</udiDi>
    <basicUdiDi>B-06934175009428</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName>Serum amyloid A Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>12600549</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:07:24.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175009411</udiDi>
    <basicUdiDi>B-06934175009411</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName>Heart-type fatty acid-binding protein Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>12600548</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:07:23.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175009398</udiDi>
    <basicUdiDi>B-06934175009398</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName>Pepsinogen I/Pepsinogen II Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>12600550</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:07:20.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175009381</udiDi>
    <basicUdiDi>B-06934175009381</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName>Homocysteine Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>12600545</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:07:19.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175009350</udiDi>
    <basicUdiDi>B-06934175009350</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName>C-Reactive Protein/Anti-streptolysin O/Rheumatoid Factor Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>12600542</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:07:18.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934175009374</udiDi>
    <basicUdiDi>B-06934175009374</basicUdiDi>
    <tradeName>Sinocare</tradeName>
    <deviceName>Immunoglobulin (IgA/IgG/IgM)Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>12600544</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:07:16.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933420100620</udiDi>
    <basicUdiDi>B-06933420100620</basicUdiDi>
    <tradeName>Diather</tradeName>
    <deviceName>One Step Semi-Quantitative HCG Urine Pregnancy Test</deviceName>
    <manufacturerName>Blue Cross Bio-Medical (Beijing) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000033173</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33BPL02 (1 Test/Kit)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:06:51.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289860659</udiDi>
    <basicUdiDi>B-06933289860659</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>17α-OH Progesterone (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZB3P0004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:06:50.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289860642</udiDi>
    <basicUdiDi>B-06933289860642</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>17α-OH Progesterone (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZB3P0003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:06:49.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289860635</udiDi>
    <basicUdiDi>B-06933289860635</basicUdiDi>
    <tradeName>SmarLumi</tradeName>
    <deviceName>17α-OH Progesterone (CLIA)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZB3P0002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-03T10:06:47.952Z</lastUpdated>
  </row>
</eudamedExport>