<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-77H50TSCW5</udiDi>
    <basicUdiDi>B-77H50TSCW5</basicUdiDi>
    <tradeName>Cystatin C (CYS-C) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Cystatin C (CYS-C) Assay Kit (Immunoturbidimetric 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77H50TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:28.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77H150TSCC6</udiDi>
    <basicUdiDi>B-77H150TSCC6</basicUdiDi>
    <tradeName>Cystatin C (CYS-C) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Cystatin C (CYS-C) Assay Kit (Immunoturbidimetric 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>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77H150TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:27.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-730000NK</udiDi>
    <basicUdiDi>B-730000NK</basicUdiDi>
    <tradeName>ZuhauseTEST CRP</tradeName>
    <deviceName>ZuhauseTEST CRP</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>730000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:03.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-475106QC</udiDi>
    <basicUdiDi>B-475106QC</basicUdiDi>
    <tradeName>Prealbumin Reagent (PAB 2 x 100)</tradeName>
    <deviceName>Prealbumin Reagent (PAB 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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475106</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:06:27.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-475100PY</udiDi>
    <basicUdiDi>B-475100PY</basicUdiDi>
    <tradeName>Microalbumin Reagent (MA 2 x 100)</tradeName>
    <deviceName>Microalbumin Reagent (MA 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>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:06:07.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467942RT</udiDi>
    <basicUdiDi>B-467942RT</basicUdiDi>
    <tradeName>Transferrin Reagent (TRFN 2 x 150)</tradeName>
    <deviceName>Transferrin Reagent (TRFN 2 x 150)</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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467942</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:34.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467930RL</udiDi>
    <basicUdiDi>B-467930RL</basicUdiDi>
    <tradeName>Immunoglobulin M Reagent (Ig-M 2 x 150)</tradeName>
    <deviceName>Immunoglobulin M Reagent (Ig-M 2 x 150)</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>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467930</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:32.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467925RT</udiDi>
    <basicUdiDi>B-467925RT</basicUdiDi>
    <tradeName>Immunoglobulin G Reagent (Ig-G 2 x 150)</tradeName>
    <deviceName>Immunoglobulin G Reagent (Ig-G 2 x 150)</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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467925</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:30.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467920RH</udiDi>
    <basicUdiDi>B-467920RH</basicUdiDi>
    <tradeName>Immunoglobulin A Reagent (Ig-A 2 x 150)</tradeName>
    <deviceName>Immunoglobulin A Reagent (Ig-A 2 x 150)</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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467920</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:29.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467905RM</udiDi>
    <basicUdiDi>B-467905RM</basicUdiDi>
    <tradeName>Apolipoprotein B Reagent (ApoB 2 x 100)</tradeName>
    <deviceName>Apolipoprotein B Reagent (ApoB 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>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467905</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:25.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-467900RB</udiDi>
    <basicUdiDi>B-467900RB</basicUdiDi>
    <tradeName>Apolipoprotein A Reagent (ApoA 2 x 100)</tradeName>
    <deviceName>Apolipoprotein A Reagent (ApoA 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>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>467900</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:24.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447790R6</udiDi>
    <basicUdiDi>B-447790R6</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin 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>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447790</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:48:00.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447750QS</udiDi>
    <basicUdiDi>B-447750QS</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems AT3 Antithrombin III 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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447750</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:56.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447740QP</udiDi>
    <basicUdiDi>B-447740QP</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin 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>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447740</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:55.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447780R3</udiDi>
    <basicUdiDi>B-447780R3</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein 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>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447780</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:54.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447760QV</udiDi>
    <basicUdiDi>B-447760QV</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems PFB Properdin Factor B 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>W0102010299</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447760</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:53.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447730QL</udiDi>
    <basicUdiDi>B-447730QL</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems APB Apolipoprotein B 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>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447730</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:36.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447720QH</udiDi>
    <basicUdiDi>B-447720QH</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems CER Ceruloplasmin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems CER Ceruloplasmin 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>W0102010301</emdnCode>
    <emdnDescription>CERULOPLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447720</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:35.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447710QE</udiDi>
    <basicUdiDi>B-447710QE</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin 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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447710</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:34.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447700QB</udiDi>
    <basicUdiDi>B-447700QB</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems TRU Urine Transferrin Reagent</tradeName>
    <deviceName>447700</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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447700</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:34.109Z</lastUpdated>
  </row>
</eudamedExport>