<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R03312ZF</udiDi>
    <basicUdiDi>B-R03312ZF</basicUdiDi>
    <tradeName>D-R03312ZF</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>R03312</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:52:35.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182707682</udiDi>
    <basicUdiDi>B-62230182707682</basicUdiDi>
    <tradeName>Alpha Amylase (4+1) GALG2-CNP</tradeName>
    <deviceName>Alpha Amylase (4+1) GALG2-CNP</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-606 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:34:17.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182707750</udiDi>
    <basicUdiDi>B-62230182707750</basicUdiDi>
    <tradeName>Alpha Amylase (4+1) GALG2-CNP</tradeName>
    <deviceName>Alpha Amylase (4+1) GALG2-CNP</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-606 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:34:14.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041004068</udiDi>
    <basicUdiDi>B-62230041004068</basicUdiDi>
    <tradeName>Alpha Amylase - GALG2-Cnp 2 reagents (4+1)</tradeName>
    <deviceName>Amylase (4+1)</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Zl-219 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:11:47.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700801016</udiDi>
    <basicUdiDi>37017008AMSL0193</basicUdiDi>
    <tradeName>AMYLASE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMSL-5M30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:59.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700815716</udiDi>
    <basicUdiDi>37017008AMSL008Z</basicUdiDi>
    <tradeName>AMYLASE SL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMSL-5220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:55.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700815808</udiDi>
    <basicUdiDi>37017008AMSL008Z</basicUdiDi>
    <tradeName>AMYLASE SL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMSL-0390</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:55.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700815815</udiDi>
    <basicUdiDi>37017008AMSL008Z</basicUdiDi>
    <tradeName>AMYLASE SL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMSL-5405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:55.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700815907</udiDi>
    <basicUdiDi>37017008AMSL008Z</basicUdiDi>
    <tradeName>AMYLASE SL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMSL-0400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:55.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034063843078</udiDi>
    <basicUdiDi>B-08034063843078</basicUdiDi>
    <tradeName>AMYLASE CNPG3</tradeName>
    <deviceName>AMYLASE CNPG3</deviceName>
    <manufacturerName>FAR Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000041136</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL05-150</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:27:02.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KHB1159J</udiDi>
    <basicUdiDi>B-KHB1159J</basicUdiDi>
    <tradeName>D-KHB1159J</tradeName>
    <deviceName>α-Amylase Kit (CNPG3 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>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:39:19.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01062165X</udiDi>
    <basicUdiDi>B-ECH01062165X</basicUdiDi>
    <tradeName>D-ECH01062165X</tradeName>
    <deviceName>α-Amylase (AMY)</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>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0106216</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:37:45.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01032165A</udiDi>
    <basicUdiDi>B-ECH01032165A</basicUdiDi>
    <tradeName>D-ECH01032165A</tradeName>
    <deviceName>α-Amylase (AMY)</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>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0103216</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:31.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01012164U</udiDi>
    <basicUdiDi>B-ECH01012164U</basicUdiDi>
    <tradeName>D-ECH01012164U</tradeName>
    <deviceName>α-Amylase (AMY)</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>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101216</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:34:25.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C0160LB</udiDi>
    <basicUdiDi>B-C0160LB</basicUdiDi>
    <tradeName>Amylase</tradeName>
    <deviceName>Amylase</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C0160</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:49:19.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AmylaseAX</udiDi>
    <basicUdiDi>B-AmylaseAX</basicUdiDi>
    <tradeName>Amylase</tradeName>
    <deviceName>Amylase</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>(Amy-Mk-100)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:46:00.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AMY601CN</udiDi>
    <basicUdiDi>B-AMY601CN</basicUdiDi>
    <tradeName>Amylase Reagent Kit</tradeName>
    <deviceName>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>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMY6011Y, AMY6012Y, AMY6013Y, AMY6014Y, AMY6015Y, AMY6011N, AMY6012N, AMY6013N, AMY6014N, AMY6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:41.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AMILASE-LRGQ</udiDi>
    <basicUdiDi>B-AMILASE-LRGQ</basicUdiDi>
    <tradeName>AMILASI LR Reattivo Liquido</tradeName>
    <deviceName>AMILASI LR reattivo liquido</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC220</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:35:26.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A71607V7</udiDi>
    <basicUdiDi>B-A71607V7</basicUdiDi>
    <tradeName>Amylase Reagent (AMY7 2 x 200)</tradeName>
    <deviceName>Amylase Reagent (AMY7 2 x 200)</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>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A71607</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:43.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>8053617720146ZV</udiDi>
    <basicUdiDi>B-8053617720146ZV</basicUdiDi>
    <tradeName>Amylase CNPG3 LS Mono</tradeName>
    <deviceName>Amylase CNPG3 LS Mono</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010107</emdnCode>
    <emdnDescription>AMYLASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC1020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:32:17.344Z</lastUpdated>
  </row>
</eudamedExport>