<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ECH05030556W</udiDi>
    <basicUdiDi>B-ECH05030556W</basicUdiDi>
    <tradeName>D-ECH05030556W</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>ECH0503055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:44:25.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05020556P</udiDi>
    <basicUdiDi>B-ECH05020556P</basicUdiDi>
    <tradeName>D-ECH05020556P</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>ECH0502055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:36.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05010556G</udiDi>
    <basicUdiDi>B-ECH05010556G</basicUdiDi>
    <tradeName>D-ECH05010556G</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>ECH0501055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:04.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01090556L</udiDi>
    <basicUdiDi>B-ECH01090556L</basicUdiDi>
    <tradeName>D-ECH01090556L</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>ECH0109055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:19.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01030555A</udiDi>
    <basicUdiDi>B-ECH01030555A</basicUdiDi>
    <tradeName>D-ECH01030555A</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>ECH0103055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:19.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01010554U</udiDi>
    <basicUdiDi>B-ECH01010554U</basicUdiDi>
    <tradeName>D-ECH01010554U</tradeName>
    <deviceName>β2-Microglobulin（β2-MG）</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</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>ECH0101055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:29.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B2-MG601SS</udiDi>
    <basicUdiDi>B-B2-MG601SS</basicUdiDi>
    <tradeName>β2-Microglobulin Reagent Kit</tradeName>
    <deviceName>β2-Microglobulin 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>β2-MG6011Y, β2-MG6012Y, β2-MG6013Y, β2-MG6014Y, β2-MG6015Y, β2-MG6011N, β2-MG6012N, β2-MG6013N, β2-MG6014N, β2-MG6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:49:50.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M19FH</udiDi>
    <basicUdiDi>B-7M19FH</basicUdiDi>
    <tradeName>β2-Microglobulin assay (CLIA)</tradeName>
    <deviceName>β2-Microglobulin assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M19V1-B-EU, 7M19U1-B-EU, 7M19P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:41.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-76H50TXL</udiDi>
    <basicUdiDi>B-76H50TXL</basicUdiDi>
    <tradeName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76H50T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:18.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-76H50TSCVL</udiDi>
    <basicUdiDi>B-76H50TSCVL</basicUdiDi>
    <tradeName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76H50TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:16.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-76H150TAX</udiDi>
    <basicUdiDi>B-76H150TAX</basicUdiDi>
    <tradeName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76H150T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:14.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-76H150TSCBK</udiDi>
    <basicUdiDi>B-76H150TSCBK</basicUdiDi>
    <tradeName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76H150TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:12.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185400943</udiDi>
    <basicUdiDi>B-14562185400943</basicUdiDi>
    <tradeName>14562185400943</tradeName>
    <deviceName>CL AIA-PACK β2-Microglobulin ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029241</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:07:49.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185400936</udiDi>
    <basicUdiDi>B-14562185400936</basicUdiDi>
    <tradeName>14562185400936</tradeName>
    <deviceName>CL AIA-PACK β2-Microglobulin TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029141</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:07:34.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189210261</udiDi>
    <basicUdiDi>B-14560189210261</basicUdiDi>
    <tradeName>14560189210261</tradeName>
    <deviceName>ST AIA-PACK BMG</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0025259</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:01:16.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11K7Y</udiDi>
    <basicUdiDi>B-11K7Y</basicUdiDi>
    <tradeName>D-11K7Y</tradeName>
    <deviceName>β2-Microglobulin Test Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:44.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250889</udiDi>
    <basicUdiDi>B-08683548250889</basicUdiDi>
    <tradeName>RapidFor™ β2-Microglobulin Rapid Test Kit (FIA)</tradeName>
    <deviceName>β2-Microglobulin Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:10:53.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359549110</udiDi>
    <basicUdiDi>697015090000012GP</basicUdiDi>
    <tradeName>β2-Microglobulin CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMB1005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:38:13.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287119251</udiDi>
    <basicUdiDi>B-08435287119251</basicUdiDi>
    <tradeName>08435287119251</tradeName>
    <deviceName>beta2-MICROGLOBULIN</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31925</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:47:43.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287119206</udiDi>
    <basicUdiDi>B-08435287119206</basicUdiDi>
    <tradeName>08435287119206</tradeName>
    <deviceName>beta2-MICROGLOBULIN</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31920</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:47:37.565Z</lastUpdated>
  </row>
</eudamedExport>