<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>15099590000400</udiDi>
    <basicUdiDi>150995901OSR60180SR</basicUdiDi>
    <tradeName>P-5-P</tradeName>
    <deviceName>P-5-P</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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR60180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:27:48.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590000035</udiDi>
    <basicUdiDi>150995901OSR6006LS</basicUdiDi>
    <tradeName>α-AMYLASE</tradeName>
    <deviceName>α-AMYLASE</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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6006</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:27:34.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-62H30TSCS7</udiDi>
    <basicUdiDi>B-62H30TSCS7</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Assay Kit (Enzymatic Colorimetric Method)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Assay Kit (Enzymatic Colorimetric 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62H30TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:40:52.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-62H150TSC8G</udiDi>
    <basicUdiDi>B-62H150TSC8G</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Assay Kit (Enzymatic Colorimetric Method)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Assay Kit (Enzymatic Colorimetric 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62H150TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:39:37.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-32A7</udiDi>
    <basicUdiDi>B-6-32A7</basicUdiDi>
    <tradeName>D-6-32A7</tradeName>
    <deviceName>Mitochondrial Aspartate Aminotranferase (mAST) Assay Kit (Enzymatic Inhibition 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U87382020M, U87382040M, U87389060M, U87385020M, U87320060M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:12:35.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-119X</udiDi>
    <basicUdiDi>B-6-119X</basicUdiDi>
    <tradeName>D-6-119X</tradeName>
    <deviceName>Monoamine Oxidase (MAO) Test Kit (Continuous Monitoring 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U87081030M, U87087050M, U87089050M, U87085020M, U87011020M, U87021050M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:17.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145557447</udiDi>
    <basicUdiDi>69471455636WS</basicUdiDi>
    <tradeName>Biossays Superoxide Dismutase (Pyrogallol Substrate)</tradeName>
    <deviceName>Superoxide Dismutase (Pyrogallol Substrate)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130503011S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:39.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145548704</udiDi>
    <basicUdiDi>69471455566WW</basicUdiDi>
    <tradeName>Biossays Mitochondrial Aspartate Aminotransferase (Immune Inhibition)</tradeName>
    <deviceName>Mitochondrial Aspartate Aminotransferase (Immune Inhibition)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130502025S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:25.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145546489</udiDi>
    <basicUdiDi>69471455624WK</basicUdiDi>
    <tradeName>Biossays Monoamine oxidase (Glutamate dehydrogenase)</tradeName>
    <deviceName>Monoamine oxidase (Glutamate dehydrogenase)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130502024S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:22.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-P-AMY601C7</udiDi>
    <basicUdiDi>B-P-AMY601C7</basicUdiDi>
    <tradeName>Pancreatic Amylase Reagent Kit</tradeName>
    <deviceName>Pancreatic Amylase 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P-AMY6011Y, P-AMY6012Y, P-AMY6013Y, P-AMY6014Y, P-AMY6015Y, P-AMY6011N, P-AMY6012N, P-AMY6013N, P-AMY6014N, P-AMY6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:16:11.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01052065M</udiDi>
    <basicUdiDi>B-ECH01052065M</basicUdiDi>
    <tradeName>D-ECH01052065M</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Assay Kit by Enzymatic Method</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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105206</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:43.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01012154S</udiDi>
    <basicUdiDi>B-ECH01012154S</basicUdiDi>
    <tradeName>D-ECH01012154S</tradeName>
    <deviceName>AFU</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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101215</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:34:21.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01012064R</udiDi>
    <basicUdiDi>B-ECH01012064R</basicUdiDi>
    <tradeName>D-ECH01012064R</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Assay Kit by Enzymatic Method</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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101206</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:34:13.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-969650TS</udiDi>
    <basicUdiDi>B-969650TS</basicUdiDi>
    <tradeName>Pancreatic Amylase Reagent (PAM 2 x 60)</tradeName>
    <deviceName>Pancreatic Amylase Reagent (PAM 2 x 60)</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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>969650</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:58:43.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1997N</udiDi>
    <basicUdiDi>B-1997N</basicUdiDi>
    <tradeName>D-1997N</tradeName>
    <deviceName>Cholyglycine Kit (Homogeneous Enzyme Immunoassay 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:16:50.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1787E</udiDi>
    <basicUdiDi>B-1787E</basicUdiDi>
    <tradeName>D-1787E</tradeName>
    <deviceName>Glycylproline Dipeptidyl Aminopeptidase Assay Kit (Rate 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:51.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1777C</udiDi>
    <basicUdiDi>B-1777C</basicUdiDi>
    <tradeName>D-1777C</tradeName>
    <deviceName>Adenosine Deaminase Test Kit (Rate Assay)</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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:34.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-12S8K</udiDi>
    <basicUdiDi>B-12S8K</basicUdiDi>
    <tradeName>D-12S8K</tradeName>
    <deviceName>Pancreas Amylase Assay Kit (Immunosuppression and EPS Substrate 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:57:00.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11X8S</udiDi>
    <basicUdiDi>B-11X8S</basicUdiDi>
    <tradeName>D-11X8S</tradeName>
    <deviceName>α-L-Fucosidase Kit (CNPF Substrate Assay)</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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:51.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11S8G</udiDi>
    <basicUdiDi>B-11S8G</basicUdiDi>
    <tradeName>D-11S8G</tradeName>
    <deviceName>Mitochondrial Aspartate Transaminase Test Kit (Immunosuppressive Assay)</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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:50.573Z</lastUpdated>
  </row>
</eudamedExport>