<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06950334819592</udiDi>
    <basicUdiDi>B-06950334819592</basicUdiDi>
    <tradeName>N-acetyl-β-D-glucosaminidase (NAG) Detection Kit (MPT-NAG Method)</tradeName>
    <deviceName>N-acetyl-β-D-glucosaminidase (NAG) Detection Kit (MPT-NAG Method)</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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32027166</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:36:17.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-31A5</udiDi>
    <basicUdiDi>B-6-31A5</basicUdiDi>
    <tradeName>D-6-31A5</tradeName>
    <deviceName>N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit (MPT 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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U82182030M, U82189060M, U82185015M, U82111020M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:12:22.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1797G</udiDi>
    <basicUdiDi>B-1797G</basicUdiDi>
    <tradeName>D-1797G</tradeName>
    <deviceName>N-acetyl-β-D-glucosaminidase 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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:58.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129711</udiDi>
    <basicUdiDi>B-06974760129711</basicUdiDi>
    <tradeName>06974760129711</tradeName>
    <deviceName>N-acetyl-β-D-glucosaminidase (NAG) Assay Kit (MPT Substrate 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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:26.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674868316</udiDi>
    <basicUdiDi>B-06971674868316</basicUdiDi>
    <tradeName>N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit  (Colorimetric)</tradeName>
    <deviceName>N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit  (Colorimetric)</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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>质控品：2mL×1（92147）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:38:58.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674867883</udiDi>
    <basicUdiDi>B-06971674867883</basicUdiDi>
    <tradeName>N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit  (Colorimetric)</tradeName>
    <deviceName>N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit  (Colorimetric)</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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>校准品：2mL×1（91127）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:37:17.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674866640</udiDi>
    <basicUdiDi>B-06971674866640</basicUdiDi>
    <tradeName>N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit  (Colorimetric)</tradeName>
    <deviceName>N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit  (Colorimetric)</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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×1  R2:6mL×1（702）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:31:51.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674866633</udiDi>
    <basicUdiDi>B-06971674866633</basicUdiDi>
    <tradeName>N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit  (Colorimetric)</tradeName>
    <deviceName>N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit  (Colorimetric)</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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×4  R2:6mL×4（709）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:31:49.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674866626</udiDi>
    <basicUdiDi>B-06971674866626</basicUdiDi>
    <tradeName>N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit  (Colorimetric)</tradeName>
    <deviceName>N-Acetyl-β-D-Glucosaminidase (NAG) Test Kit  (Colorimetric)</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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×2  R2:20mL×2（701）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:31:48.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145518097</udiDi>
    <basicUdiDi>69471455563WQ</basicUdiDi>
    <tradeName>Biossays N-Acetyl-β-D-Glucosaminidase (MPT)</tradeName>
    <deviceName>N-Acetyl-β-D-Glucosaminidase (MPT)</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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130503009A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:19:32.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145518059</udiDi>
    <basicUdiDi>69471455563WQ</basicUdiDi>
    <tradeName>Biossays N-Acetyl-β-D-Glucosaminidase (MPT)</tradeName>
    <deviceName>N-Acetyl-β-D-Glucosaminidase (MPT)</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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130503009S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:19:31.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751857</udiDi>
    <basicUdiDi>B-06936595751857</basicUdiDi>
    <tradeName>N-Acetyl-β-D-Glucosaminidase Kit (MPT 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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ016Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:53.550Z</lastUpdated>
  </row>
</eudamedExport>