<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974760129599</udiDi>
    <basicUdiDi>B-06974760129599</basicUdiDi>
    <tradeName>06974760129599</tradeName>
    <deviceName>Homocysteine （HCY）Assay Kit (Enzymatic Cycling 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>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL, Calibrator: 2×0.5 mL (2 levels, optional), Control: 2×0.5 mL (2 levels, optional)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:07.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129582</udiDi>
    <basicUdiDi>B-06974760129582</basicUdiDi>
    <tradeName>06974760129582</tradeName>
    <deviceName>Pepsinogen Ⅱ(PGⅡ)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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×54 mL, R2: 2×10 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:05.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129575</udiDi>
    <basicUdiDi>B-06974760129575</basicUdiDi>
    <tradeName>06974760129575</tradeName>
    <deviceName>Pepsinogen Ⅰ(PGⅠ) 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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×54 mL, R2: 2×10 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:04.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129568</udiDi>
    <basicUdiDi>B-06974760129568</basicUdiDi>
    <tradeName>06974760129568</tradeName>
    <deviceName>Heart-type Fatty Acid-Binding Protein (H-FABP) 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>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:03.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129551</udiDi>
    <basicUdiDi>B-06974760129551</basicUdiDi>
    <tradeName>06974760129551</tradeName>
    <deviceName>Cardiac Troponin I (cTnI) 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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:00.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129544</udiDi>
    <basicUdiDi>B-06974760129544</basicUdiDi>
    <tradeName>06974760129544</tradeName>
    <deviceName>Neutrophil Gelatinase-associated Lipocalin (NGAL)Assay Kit(Latex lmmunoturbidimetric 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>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:39:59.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129537</udiDi>
    <basicUdiDi>B-06974760129537</basicUdiDi>
    <tradeName>06974760129537</tradeName>
    <deviceName>Myeloperoxidase (MPO) 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>W01021310</emdnCode>
    <emdnDescription>MYELOPEROXIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×45 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:39:58.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129520</udiDi>
    <basicUdiDi>B-06974760129520</basicUdiDi>
    <tradeName>06974760129520</tradeName>
    <deviceName>Serum Amyloid A Protein (SAA) 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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:39:56.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129490</udiDi>
    <basicUdiDi>B-06974760129490</basicUdiDi>
    <tradeName>06974760129490</tradeName>
    <deviceName>β2-Microglobulin (β2-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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 1×16 mL, R2: 1×4 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:39:54.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129513</udiDi>
    <basicUdiDi>B-06974760129513</basicUdiDi>
    <tradeName>06974760129513</tradeName>
    <deviceName>Cystatin C (CysC)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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×54 mL, R2: 2×18 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:39:52.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129506</udiDi>
    <basicUdiDi>B-06974760129506</basicUdiDi>
    <tradeName>06974760129506</tradeName>
    <deviceName>Myoglobin (MYO) Assay Kit (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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×45 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:39:52.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129414</udiDi>
    <basicUdiDi>B-06974760129414</basicUdiDi>
    <tradeName>06974760129414</tradeName>
    <deviceName>Glycated Albumin (GA)Assay Kit (Enzymatic 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>W0102060199</emdnCode>
    <emdnDescription>DIABETES ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>942</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:39:50.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974760129315</udiDi>
    <basicUdiDi>B-06974760129315</basicUdiDi>
    <tradeName>06974760129315</tradeName>
    <deviceName>Full-Range C-Reactive Protein (fCRP) 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>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 1×16 mL, R2: 1×8 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:39:35.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937287300698</udiDi>
    <basicUdiDi>69372873AMTECHSTEN</basicUdiDi>
    <tradeName>06937287300698</tradeName>
    <deviceName>Automatic specific protein analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST-280p</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:14:42.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937287300681</udiDi>
    <basicUdiDi>B-06937287300681</basicUdiDi>
    <tradeName>06937287300681</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>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:49.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937287300674</udiDi>
    <basicUdiDi>B-06937287300674</basicUdiDi>
    <tradeName>06937287300674</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>W0102030104</emdnCode>
    <emdnDescription>CANCER ANTIGEN 50</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:46.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937287300667</udiDi>
    <basicUdiDi>B-06937287300667</basicUdiDi>
    <tradeName>06937287300667</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>W0102030121</emdnCode>
    <emdnDescription>PRO-GASTRIN-RELEASING PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:45.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937287300650</udiDi>
    <basicUdiDi>B-06937287300650</basicUdiDi>
    <tradeName>06937287300650</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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:44.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937287300643</udiDi>
    <basicUdiDi>B-06937287300643</basicUdiDi>
    <tradeName>06937287300643</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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:42.036Z</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>
</eudamedExport>