<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-77947KK</udiDi>
    <basicUdiDi>B-77947KK</basicUdiDi>
    <tradeName>SPOTCHEM D IP</tradeName>
    <deviceName>SPOTCHEM D IP</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010307</emdnCode>
    <emdnDescription>PHOSPHATE INORGANIC / PHOSPHORUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77947</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:24:59.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77939KL</udiDi>
    <basicUdiDi>B-77939KL</basicUdiDi>
    <tradeName>SPOTCHEM D Ca</tradeName>
    <deviceName>SPOTCHEM D Ca</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77939</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:24:34.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77487K6</udiDi>
    <basicUdiDi>B-77487K6</basicUdiDi>
    <tradeName>SPOTCHEM II Calcium</tradeName>
    <deviceName>SPOTCHEM II Calcium</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77487</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:56.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77415JD</udiDi>
    <basicUdiDi>B-77415JD</basicUdiDi>
    <tradeName>SPOTCHEM II Magnesium</tradeName>
    <deviceName>SPOTCHEM II Magnesium</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010306</emdnCode>
    <emdnDescription>MAGNESIUM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77415</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:25.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77414JB</udiDi>
    <basicUdiDi>B-77414JB</basicUdiDi>
    <tradeName>SPOTCHEM II Inorganic Phosphorus</tradeName>
    <deviceName>SPOTCHEM II Inorganic Phosphorus</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010307</emdnCode>
    <emdnDescription>PHOSPHATE INORGANIC / PHOSPHORUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77414</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:24.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77180J9</udiDi>
    <basicUdiDi>B-77180J9</basicUdiDi>
    <tradeName>SPOTCHEM II Magnesium</tradeName>
    <deviceName>SPOTCHEM II Magnesium</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010306</emdnCode>
    <emdnDescription>MAGNESIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77180</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:54.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77179JQ</udiDi>
    <basicUdiDi>B-77179JQ</basicUdiDi>
    <tradeName>SPOTCHEM II Inorganic Phosphorus</tradeName>
    <deviceName>SPOTCHEM II Inorganic Phosphorus</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010307</emdnCode>
    <emdnDescription>PHOSPHATE INORGANIC / PHOSPHORUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77179</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:52.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77166JF</udiDi>
    <basicUdiDi>B-77166JF</basicUdiDi>
    <tradeName>SPOTCHEM II Calcium</tradeName>
    <deviceName>SPOTCHEM II Calcium</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77166</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:33.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75304HM</udiDi>
    <basicUdiDi>B-75304HM</basicUdiDi>
    <tradeName>AMMONIA TEST KIT II</tradeName>
    <deviceName>AMMONIA TEST KIT II</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010301</emdnCode>
    <emdnDescription>AMMONIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75304</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:23.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-472515QC</udiDi>
    <basicUdiDi>B-472515QC</basicUdiDi>
    <tradeName>SYNCHRON Systems CO2 Alkaline Buffer</tradeName>
    <deviceName>SYNCHRON Systems CO2 Alkaline Buffer</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>W01010302</emdnCode>
    <emdnDescription>BICARBONATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>472515</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:58:15.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-472481QL</udiDi>
    <basicUdiDi>B-472481QL</basicUdiDi>
    <tradeName>SYNCHRON LX/DxC CO2 Acid Reagent</tradeName>
    <deviceName>SYNCHRON LX/DxC CO2 Acid Reagent</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>W01010302</emdnCode>
    <emdnDescription>BICARBONATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>472481</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:58:07.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467868S8</udiDi>
    <basicUdiDi>B-467868S8</basicUdiDi>
    <tradeName>SYNCHRON Systems Phosphorus Reagent</tradeName>
    <deviceName>SYNCHRON Systems Phosphorus Reagent</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>W01010307</emdnCode>
    <emdnDescription>PHOSPHATE INORGANIC / PHOSPHORUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467868</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:23.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-445360PT</udiDi>
    <basicUdiDi>B-445360PT</basicUdiDi>
    <tradeName>Magnesium Reagent (MG 2 x 100)</tradeName>
    <deviceName>Magnesium Reagent (MG 2 x 100)</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>W01010306</emdnCode>
    <emdnDescription>MAGNESIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>445360</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:23.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-439770R3</udiDi>
    <basicUdiDi>B-439770R3</basicUdiDi>
    <tradeName>Ammonia Reagent (AMM 2 x 25)</tradeName>
    <deviceName>Ammonia Reagent (AMM 2 x 25)</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>W01010301</emdnCode>
    <emdnDescription>AMMONIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>439770</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:44:54.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>42625753900856</udiDi>
    <basicUdiDi>B-42625753900856</basicUdiDi>
    <tradeName>Z-Elite Pro+ Reagent pack</tradeName>
    <deviceName>Z-Elite Pro+ Reagent pack</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010399</emdnCode>
    <emdnDescription>ELECTROLYTES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZA-ER4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:30.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>42625753900788</udiDi>
    <basicUdiDi>B-42625753900788</basicUdiDi>
    <tradeName>Z-Elite Reagent Pack</tradeName>
    <deviceName>Z-Elite Reagent Pack</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010399</emdnCode>
    <emdnDescription>ELECTROLYTES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZA-ER3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:29.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970301471018</udiDi>
    <basicUdiDi>B-16970301471018</basicUdiDi>
    <tradeName>16970301471018</tradeName>
    <deviceName>Ammonia Assay Kit (AMM)</deviceName>
    <manufacturerName>Beijing Strong Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000004362</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010301</emdnCode>
    <emdnDescription>AMMONIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EGSAMM</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:22:46.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-153H20TSC3X</udiDi>
    <basicUdiDi>B-153H20TSC3X</basicUdiDi>
    <tradeName>Calcium (Ca) Assay Kit (Arsenazo III Method)</tradeName>
    <deviceName>Calcium (Ca) Assay Kit (Arsenazo III Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153H20TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:47:17.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-153H200TSCKQ</udiDi>
    <basicUdiDi>B-153H200TSCKQ</basicUdiDi>
    <tradeName>Calcium (Ca) Assay Kit (Arsenazo III Method)</tradeName>
    <deviceName>Calcium (Ca) Assay Kit (Arsenazo III Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010303</emdnCode>
    <emdnDescription>CALCIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153H200TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:47:16.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-148H60TSC7D</udiDi>
    <basicUdiDi>B-148H60TSC7D</basicUdiDi>
    <tradeName>Phosphorus (P) Assay Kit (Phosphomolybdate Method)</tradeName>
    <deviceName>Phosphorus (P) Assay Kit (Phosphomolybdate Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010307</emdnCode>
    <emdnDescription>PHOSPHATE INORGANIC / PHOSPHORUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>148H60TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:27:51.529Z</lastUpdated>
  </row>
</eudamedExport>