<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-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>D-AFU6019D</udiDi>
    <basicUdiDi>B-AFU6019D</basicUdiDi>
    <tradeName>α-L-Fucosidase Reagent Kit</tradeName>
    <deviceName>α-L-Fucosidase Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>AFU6011Y, AFU6012Y, AFU6013Y, AFU6014Y, AFU6015Y, AFU6011N, AFU6012N, AFU6013N, AFU6014N, AFU6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:33:33.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937287300636</udiDi>
    <basicUdiDi>B-06937287300636</basicUdiDi>
    <tradeName>06937287300636</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039018</emdnCode>
    <emdnDescription>ALPHA-FUCOSIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:40.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751826</udiDi>
    <basicUdiDi>B-06936595751826</basicUdiDi>
    <tradeName>α-L-Fucosidase Kit (Kinetic Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039018</emdnCode>
    <emdnDescription>ALPHA-FUCOSIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ013Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:48.733Z</lastUpdated>
  </row>
</eudamedExport>