<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970522640531</udiDi>
    <basicUdiDi>B-06970522640531</basicUdiDi>
    <tradeName>Calprotectin (Cal) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Calprotectin   (Cal) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:24.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640432</udiDi>
    <basicUdiDi>B-06970522640432</basicUdiDi>
    <tradeName>Fecal Occult Blood &amp; Transferrin(FOB&amp;TF) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Fecal Occult Blood &amp; Transferrin(FOB&amp;TF) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:22.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640425</udiDi>
    <basicUdiDi>B-06970522640425</basicUdiDi>
    <tradeName>Fecal Occult Blood &amp; Transferrin(FOB&amp;TF) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Fecal Occult Blood &amp; Transferrin(FOB&amp;TF) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0302</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:20.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640395</udiDi>
    <basicUdiDi>B-06970522640395</basicUdiDi>
    <tradeName>Lactose Test Kit (Enzyme Chromatography)</tradeName>
    <deviceName>Lactose Test Kit (Enzyme Chromatography)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0702</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:16.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640388</udiDi>
    <basicUdiDi>B-06970522640388</basicUdiDi>
    <tradeName>Norovirus Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Norovirus Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB1301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:14.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640326</udiDi>
    <basicUdiDi>B-06970522640326</basicUdiDi>
    <tradeName>Transferrin (TF) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Transferrin (TF) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0203</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:13.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640319</udiDi>
    <basicUdiDi>B-06970522640319</basicUdiDi>
    <tradeName>Transferrin (TF) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Transferrin (TF) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0202</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:10.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640234</udiDi>
    <basicUdiDi>B-06970522640234</basicUdiDi>
    <tradeName>Fecal Occult Blood (FOB) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Fecal Occult Blood (FOB) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0103</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:07.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640227</udiDi>
    <basicUdiDi>B-06970522640227</basicUdiDi>
    <tradeName>Fecal Occult Blood (FOB) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Fecal Occult Blood (FOB) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:04.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640128</udiDi>
    <basicUdiDi>697052264SJPOX0003UP</basicUdiDi>
    <tradeName>Sample Diluent</tradeName>
    <deviceName>Sample Diluent</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.8L/ barrel ×2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:03.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640111</udiDi>
    <basicUdiDi>697052264SJPOX0003UP</basicUdiDi>
    <tradeName>Sample Diluent</tradeName>
    <deviceName>Sample Diluent</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.8L/ barrel</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:01.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640074</udiDi>
    <basicUdiDi>697052264YQ10KG</basicUdiDi>
    <tradeName>Sample Collection Tube</tradeName>
    <deviceName>Sample Collection Tube</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QD2101W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:44:57.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640043</udiDi>
    <basicUdiDi>697052264YQ08KV</basicUdiDi>
    <tradeName>Automatic Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Automatic Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020103</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput &gt; 250 and &lt;= 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QD0301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:44:55.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522640036</udiDi>
    <basicUdiDi>697052264YQ03KK</basicUdiDi>
    <tradeName>Automatic Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Automatic Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QD0201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:44:53.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942028509049</udiDi>
    <basicUdiDi>697052264YQ12KL</basicUdiDi>
    <tradeName>Disposable Sample Cups</tradeName>
    <deviceName>Disposable Sample Cups</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QD2601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:17:30.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942028508936</udiDi>
    <basicUdiDi>B-06942028508936</basicUdiDi>
    <tradeName>Interferon-Gamma Release Assay for Mycobacterium tuberculosis Test Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Interferon-Gamma Release Assay for Mycobacterium tuberculosis Test Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DF1800</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:17:27.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942028508790</udiDi>
    <basicUdiDi>B-06942028508790</basicUdiDi>
    <tradeName>Insulin-like Growth Factor-1 (IGF-1) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Insulin-like Growth Factor-1 (IGF-1) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060403</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2801</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:17:19.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942028508752</udiDi>
    <basicUdiDi>B-06942028508752</basicUdiDi>
    <tradeName>Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL2701</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:17:18.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942028504938</udiDi>
    <basicUdiDi>B-06942028504938</basicUdiDi>
    <tradeName>Vascular Endothelial Growth Factor(VEGF) Assay Kit(Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Vascular Endothelial Growth Factor(VEGF) Assay Kit(Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060408</emdnCode>
    <emdnDescription>VASOPRESSIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD2701</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:17:16.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942028504778</udiDi>
    <basicUdiDi>B-06942028504778</basicUdiDi>
    <tradeName>Soluble Growth Stimulation Expressed Gene 2 (ST2) Assay Kit   (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Soluble Growth Stimulation Expressed Gene 2 (ST2) Assay Kit   (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021314</emdnCode>
    <emdnDescription>ST2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA3201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:17:13.305Z</lastUpdated>
  </row>
</eudamedExport>