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<eudamedExport entity="devices">
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    <udiDi>00630414238364</udiDi>
    <basicUdiDi>0405686901755W6</basicUdiDi>
    <tradeName>Atellica CH Pancreatic Amylase_2 (PAMY_2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_PAMY</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097579</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:41.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-28AG</udiDi>
    <basicUdiDi>B-6-28AG</basicUdiDi>
    <tradeName>D-6-28AG</tradeName>
    <deviceName>Pancreatic Amylase Reagent Kit (EPS Substrate 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>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U86282040M, U86289060M, U86285020M, U86211020M, U86220060M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:12:18.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156097727</udiDi>
    <basicUdiDi>8592156CCRE0005ST</basicUdiDi>
    <tradeName>P AMY 100</tradeName>
    <deviceName>PANCREATIC AMYLASE</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLT00067</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:29:03.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145558161</udiDi>
    <basicUdiDi>69471455639WY</basicUdiDi>
    <tradeName>Biossays Pancreatic Amylase (Immunoinhibition-EPS)</tradeName>
    <deviceName>Pancreatic Amylase (Immunoinhibition-EPS)</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>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130506003S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:41.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145558192</udiDi>
    <basicUdiDi>69471455639WY</basicUdiDi>
    <tradeName>Biossays Pancreatic Amylase (Immunoinhibition-EPS)</tradeName>
    <deviceName></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>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130506003A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:56.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145558222</udiDi>
    <basicUdiDi>69471455639WY</basicUdiDi>
    <tradeName>Biossays Pancreatic Amylase Calibrator</tradeName>
    <deviceName></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>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160202639C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:56.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145558239</udiDi>
    <basicUdiDi>69471455639WY</basicUdiDi>
    <tradeName>Biossays Pancreatic Amylase Controls</tradeName>
    <deviceName></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>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160202639Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:56.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226003253</udiDi>
    <basicUdiDi>8904226079LS2004S</basicUdiDi>
    <tradeName>AUTOSPAN</tradeName>
    <deviceName>AUTOSPAN® Liquid Gold α-AMYLASE</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79LS200-05, 79LS200-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:34.098Z</lastUpdated>
  </row>
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