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<eudamedExport entity="devices">
  <row>
    <udiDi>04050598167100</udiDi>
    <basicUdiDi>B-04050598167100</basicUdiDi>
    <tradeName>α1-Mikroglobulin ELISA</tradeName>
    <deviceName>α1-Mikroglobulin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700019361</udiDi>
    <basicUdiDi>5051700NK036.U.OPTQM</basicUdiDi>
    <tradeName>Optilite® Alpha-1-Microglobulin Urine Control Pack</tradeName>
    <deviceName>Optilite® Alpha-1-microglobulin Urine Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ036.U.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:05:49.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987503610119</udiDi>
    <basicUdiDi>4987503A1MGUWK</basicUdiDi>
    <tradeName>α1-Microglobulin</tradeName>
    <deviceName>a1-Microglobulin</deviceName>
    <manufacturerName>Denka Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000015952</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08944539190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:30.933Z</lastUpdated>
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  <row>
    <udiDi>15099590180140</udiDi>
    <basicUdiDi>150995901447710LB</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447710</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:31:51.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334819561</udiDi>
    <basicUdiDi>B-06950334819561</basicUdiDi>
    <tradeName>α1-Microglobulin (α1-MG) Detection Kit (Nephelometry)</tradeName>
    <deviceName>α1-Microglobulin (α1-MG) Detection Kit (Nephelometry)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32027168</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:36:15.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768012938</udiDi>
    <basicUdiDi>0405686900892WA</basicUdiDi>
    <tradeName>N a1-Microglobulin Kit</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT_N_a1-MIC_Kit</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446619</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:33.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-a1-MG6019S</udiDi>
    <basicUdiDi>B-a1-MG6019S</basicUdiDi>
    <tradeName>α₁-Microglobulin Reagent Kit</tradeName>
    <deviceName>α₁-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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>α1-MG6011Y, α1-MG6012Y, α1-MG6013Y, α1-MG6014Y, α1-MG6015Y, α1-MG6011N, α1-MG6012N, α1-MG6013N, α1-MG6014N, α1-MG6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:18:55.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-3446</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-3446</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-3446</tradeName>
    <deviceName>Placental Alpha-1-microglobulin Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:36.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-I0212N7</udiDi>
    <basicUdiDi>B-I0212N7</basicUdiDi>
    <tradeName>α‐1 Microglobulin</tradeName>
    <deviceName>α‐1 Microglobulin</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0212</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:02:33.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05030626T</udiDi>
    <basicUdiDi>B-ECH05030626T</basicUdiDi>
    <tradeName>D-ECH05030626T</tradeName>
    <deviceName>α1-Microglobulin (α1-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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0503062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:44:27.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05020626L</udiDi>
    <basicUdiDi>B-ECH05020626L</basicUdiDi>
    <tradeName>D-ECH05020626L</tradeName>
    <deviceName>α1-Microglobulin (α1-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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0502062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:41.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05010626D</udiDi>
    <basicUdiDi>B-ECH05010626D</basicUdiDi>
    <tradeName>D-ECH05010626D</tradeName>
    <deviceName>α1-Microglobulin (α1-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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0501062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:02.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01040625E</udiDi>
    <basicUdiDi>B-ECH01040625E</basicUdiDi>
    <tradeName>D-ECH01040625E</tradeName>
    <deviceName>α1-Microglobulin (α1-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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0104062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:43.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH010306257</udiDi>
    <basicUdiDi>B-ECH010306257</basicUdiDi>
    <tradeName>D-ECH010306257</tradeName>
    <deviceName>α1-Microglobulin (α1-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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0103062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:24.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01020624Y</udiDi>
    <basicUdiDi>B-ECH01020624Y</basicUdiDi>
    <tradeName>D-ECH01020624Y</tradeName>
    <deviceName>α1-Microglobulin (α1-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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0102062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:05.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01010624R</udiDi>
    <basicUdiDi>B-ECH01010624R</basicUdiDi>
    <tradeName>D-ECH01010624R</tradeName>
    <deviceName>α1-Microglobulin (α1-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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:36.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447710QE</udiDi>
    <basicUdiDi>B-447710QE</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447710</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:34.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11L82</udiDi>
    <basicUdiDi>B-11L82</basicUdiDi>
    <tradeName>D-11L82</tradeName>
    <deviceName>α1-Microglobulin Assay 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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:44.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129810</udiDi>
    <basicUdiDi>B-06974760129810</basicUdiDi>
    <tradeName>06974760129810</tradeName>
    <deviceName>α1-Microglobulin （α 1-MG） Assay Kit （Latex Immunoturbidimetric Method）</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>IVDD</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:58.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674869337</udiDi>
    <basicUdiDi>B-06971674869337</basicUdiDi>
    <tradeName>α1-microglobulin (α1-MG) Test Kit (Latex Enhanced Immunoturbidimetric)</tradeName>
    <deviceName>α1-microglobulin (α1-MG) 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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:64mL×5  R2:16mL×5（795）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:42:26.131Z</lastUpdated>
  </row>
</eudamedExport>