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<eudamedExport entity="devices">
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    <basicUdiDi>5204309000001NC</basicUdiDi>
    <tradeName>a-AMYLASE</tradeName>
    <deviceName>a-AMYLASE</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1517-0160</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:25:43.422Z</lastUpdated>
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    <udiDi>03701700815709</udiDi>
    <basicUdiDi>37017008AMSL008Z</basicUdiDi>
    <tradeName>AMYLASE SL</tradeName>
    <deviceName>AMYLASE SL</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMSL-0230</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:50:18.020Z</lastUpdated>
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    <udiDi>03701700801009</udiDi>
    <basicUdiDi>37017008AMSL0193</basicUdiDi>
    <tradeName>AMYLASE</tradeName>
    <deviceName>AMYLASE</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMSL-M430</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:48:51.651Z</lastUpdated>
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    <basicUdiDi>150995902OSR6182N2</basicUdiDi>
    <tradeName>Alpha-amylase</tradeName>
    <deviceName>Alpha-amylase</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6182</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:29:01.643Z</lastUpdated>
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    <udiDi>04547410059700</udiDi>
    <basicUdiDi>B-04547410059700</basicUdiDi>
    <tradeName>FUJI DRI-CHEM SLIDE AMYL-P III</tradeName>
    <deviceName>FUJI DRI-CHEM SLIDE AMYL-P III</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410059700</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:10:25.943Z</lastUpdated>
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    <udiDi>08431673939830</udiDi>
    <basicUdiDi>B-08431673939830</basicUdiDi>
    <tradeName>AMYLASE-LQ</tradeName>
    <deviceName>ɑ-Amylase</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD41201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:25:42.114Z</lastUpdated>
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    <udiDi>08431673612023</udiDi>
    <basicUdiDi>B-08431673612023</basicUdiDi>
    <tradeName>AMYLASE-LQ</tradeName>
    <deviceName>ɑ-Amylase</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK41202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:25:04.248Z</lastUpdated>
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    <udiDi>08431673612016</udiDi>
    <basicUdiDi>B-08431673612016</basicUdiDi>
    <tradeName>AMYLASE-LQ</tradeName>
    <deviceName>ɑ-Amylase</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK41201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:25:01.115Z</lastUpdated>
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    <udiDi>08431673512019</udiDi>
    <basicUdiDi>B-08431673512019</basicUdiDi>
    <tradeName>AMYLASE-LQ</tradeName>
    <deviceName>ɑ-Amylase</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP41201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:24:30.584Z</lastUpdated>
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    <udiDi>08431673412029</udiDi>
    <basicUdiDi>B-08431673412029</basicUdiDi>
    <tradeName>AMYLASE-LQ</tradeName>
    <deviceName>ɑ-Amylase</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:23:36.779Z</lastUpdated>
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  <row>
    <udiDi>08431673412012</udiDi>
    <basicUdiDi>B-08431673412012</basicUdiDi>
    <tradeName>AMYLASE-LQ</tradeName>
    <deviceName>ɑ-Amylase</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:23:33.893Z</lastUpdated>
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  <row>
    <udiDi>08431673090623</udiDi>
    <basicUdiDi>B-08431673090623</basicUdiDi>
    <tradeName>AMYLASE-LQ</tradeName>
    <deviceName>ɑ-Amylase</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MX41201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:20:11.355Z</lastUpdated>
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    <udiDi>08431673088088</udiDi>
    <basicUdiDi>B-08431673088088</basicUdiDi>
    <tradeName>AMYLASE-LQ</tradeName>
    <deviceName>Amylase</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JL41201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:17:02.364Z</lastUpdated>
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    <udiDi>08431673073787</udiDi>
    <basicUdiDi>B-08431673073787</basicUdiDi>
    <tradeName>AMYLASE-LQ</tradeName>
    <deviceName>ɑ-Amylase</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI41201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:15:36.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414238357</udiDi>
    <basicUdiDi>0405686901653VV</basicUdiDi>
    <tradeName>Atellica CH Amylase_2 (AMY_2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_AMY_2</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>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097649</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:40.917Z</lastUpdated>
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    <udiDi>D-R03318ZT</udiDi>
    <basicUdiDi>B-R03318ZT</basicUdiDi>
    <tradeName>D-R03318ZT</tradeName>
    <deviceName>α-Amylase Assay Reagent Kit (EPS Method)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R03318</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:53:00.634Z</lastUpdated>
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    <udiDi>D-R03317ZR</udiDi>
    <basicUdiDi>B-R03317ZR</basicUdiDi>
    <tradeName>D-R03317ZR</tradeName>
    <deviceName>α-Amylase Assay Reagent Kit (EPS Method)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R03317</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:52:42.171Z</lastUpdated>
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    <udiDi>D-R03316ZP</udiDi>
    <basicUdiDi>B-R03316ZP</basicUdiDi>
    <tradeName>D-R03316ZP</tradeName>
    <deviceName>α-Amylase Assay Reagent Kit (EPS Method)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R03316</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:52:41.371Z</lastUpdated>
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    <udiDi>D-R03315ZM</udiDi>
    <basicUdiDi>B-R03315ZM</basicUdiDi>
    <tradeName>D-R03315ZM</tradeName>
    <deviceName>α-Amylase Assay Reagent Kit (EPS Method)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R03315</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:52:40.576Z</lastUpdated>
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    <udiDi>D-R03314ZK</udiDi>
    <basicUdiDi>B-R03314ZK</basicUdiDi>
    <tradeName>D-R03314ZK</tradeName>
    <deviceName>α-Amylase Assay Reagent Kit (EPS Method)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R03314</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:52:39.766Z</lastUpdated>
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