<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>69743840303186</udiDi>
    <basicUdiDi>B-69743840303186</basicUdiDi>
    <tradeName>FOB Rapid Test</tradeName>
    <deviceName>FOB Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3040101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:10:35.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646FOB001GESV</udiDi>
    <basicUdiDi>B-697424646FOB001GESV</basicUdiDi>
    <tradeName>Fecal Occult Blood(FOB) Rapid Test (Feces)</tradeName>
    <deviceName>Fecal Occult Blood(FOB) Rapid Test (Feces)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-5011/FOB-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:06:07.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-63H50TSCTE</udiDi>
    <basicUdiDi>B-63H50TSCTE</basicUdiDi>
    <tradeName>Alpha-L-Fucosidase (AFU) Assay Kit (Kinetic Method)</tradeName>
    <deviceName>Alpha-L-Fucosidase (AFU) Assay Kit (Kinetic Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039018</emdnCode>
    <emdnDescription>ALPHA-FUCOSIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63H50TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:41:05.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-63H240TSC95</udiDi>
    <basicUdiDi>B-63H240TSC95</basicUdiDi>
    <tradeName>Alpha-L-Fucosidase (AFU) Assay Kit (Kinetic Method)</tradeName>
    <deviceName>Alpha-L-Fucosidase (AFU) Assay Kit (Kinetic Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039018</emdnCode>
    <emdnDescription>ALPHA-FUCOSIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63H240TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:41:05.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6000A9</udiDi>
    <basicUdiDi>B-6000A9</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Serotonin 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>W0102039011</emdnCode>
    <emdnDescription>SEROTONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:15:19.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-78AX</udiDi>
    <basicUdiDi>B-6-78AX</basicUdiDi>
    <tradeName>D-6-78AX</tradeName>
    <deviceName>Neuron-specific Enolase (NSE) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000143M, USIA00000144M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:14.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-66AQ</udiDi>
    <basicUdiDi>B-6-66AQ</basicUdiDi>
    <tradeName>D-6-66AQ</tradeName>
    <deviceName>β2-Microglobulin (β2-MG) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000147M, USIA00000148M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:13:54.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-25AA</udiDi>
    <basicUdiDi>B-6-25AA</basicUdiDi>
    <tradeName>D-6-25AA</tradeName>
    <deviceName>α-L-Fucosidase (AFU) Assay Kit (CNPF substrate Method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039018</emdnCode>
    <emdnDescription>ALPHA-FUCOSIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U87481030M, U87489050M, U87485020M, U87421050M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:12:08.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339210876</udiDi>
    <basicUdiDi>B-06937339210876</basicUdiDi>
    <tradeName>FOB Rapid Test</tradeName>
    <deviceName>FOB Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTFO-U602C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:32:42.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426021334</udiDi>
    <basicUdiDi>B-00816426021334</basicUdiDi>
    <tradeName>K-ASSAY Microglobulin Urine Control</tradeName>
    <deviceName>Beta-2 Microglobulin Urine Control</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K284C-2M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:33:03.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771200493</udiDi>
    <basicUdiDi>805677131456157</basicUdiDi>
    <tradeName>LIAISON® NSE</tradeName>
    <deviceName>LIAISON® NSE</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>314561</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:08:02.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>00615233014559</udiDi>
    <basicUdiDi>06152338309JF</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395]</tradeName>
    <deviceName>Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8379-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:49.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00615233014481</udiDi>
    <basicUdiDi>06152338306J9</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-OCT3/4 Mouse Monoclonal Antibody [C-10]</tradeName>
    <deviceName>Tissue-Tek Genie® anti-OCT3/4 Mouse Monoclonal Antibody [C-10]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8288-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:45.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>00615233013996</udiDi>
    <basicUdiDi>06152338310HY</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-TRPS1 Rabbit Polyclonal Antibody [ZR382]</tradeName>
    <deviceName>Tissue-Tek Genie® anti-TRPS1 Rabbit Polyclonal Antibody [ZR382]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8359-M250</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:44.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>00615233013965</udiDi>
    <basicUdiDi>06152338300HV</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName>Tissue-Tek Genie® anti-Cadherin 17 Rabbit MonoclonalAntibody [QR098]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8364-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:43.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>00615233011435</udiDi>
    <basicUdiDi>06152338307JB</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-SALL4 Mouse Monoclonal Antibody [6E3]</tradeName>
    <deviceName>Tissue-Tek Genie® anti-SALL4 Mouse Monoclonal Antibody [6E3]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8358-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:42.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>00615233011428</udiDi>
    <basicUdiDi>06152338298K3</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName>Tissue-Tek Genie® anti-GATA3 Rabbit Monoclonal Antibody [QR018]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8357-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:38.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>00615233011350</udiDi>
    <basicUdiDi>06152338291JM</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName>Tissue-Tek Genie® anti-SATB2 Rabbit Monoclonal Antibody [QR023]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8356-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:37.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>00615233011312</udiDi>
    <basicUdiDi>06152338304J5</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]</tradeName>
    <deviceName>Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8337-M250</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:37.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>00615233010711</udiDi>
    <basicUdiDi>06152338302HZ</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-MUC2 Mouse Monoclonal Antibody [CCP58]</tradeName>
    <deviceName>Tissue-Tek Genie® anti-MUC2 Mouse Monoclonal Antibody [CCP58]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8305-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:37.547Z</lastUpdated>
  </row>
</eudamedExport>