<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-59H160TB9</udiDi>
    <basicUdiDi>B-59H160TB9</basicUdiDi>
    <tradeName>Prealbumin (PA) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Prealbumin (PA) 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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>59H160T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:04.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700823216</udiDi>
    <basicUdiDi>37017008IPAL039J</basicUdiDi>
    <tradeName>PREALBUMIN IP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPAL-6125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:15.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700823223</udiDi>
    <basicUdiDi>37017008IPAL039J</basicUdiDi>
    <tradeName>PREALBUMIN IP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPAL-5025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:15.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414614939</udiDi>
    <basicUdiDi>0405686902245VH</basicUdiDi>
    <tradeName>Atellica CH Prealbumin (PALB)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_PALB</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537217</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:43.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768011399</udiDi>
    <basicUdiDi>0405686900950VX</basicUdiDi>
    <tradeName>N Antiserum to Human Prealbumin</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_AS_PreAlb</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446452</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:13.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005725</udiDi>
    <basicUdiDi>0405686900205UP</basicUdiDi>
    <tradeName>Dimension Prealbumin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_PALB</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444978</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:52.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PA601UK</udiDi>
    <basicUdiDi>B-PA601UK</basicUdiDi>
    <tradeName>Prealbumin Reagent Kit</tradeName>
    <deviceName>Prealbumin 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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA6011Y, PA6012Y, PA6013Y, PA6014Y, PA6015Y, PA6011N, PA6012N, PA6013N, PA6014N, PA6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:32:11.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05090077V</udiDi>
    <basicUdiDi>B-ECH05090077V</basicUdiDi>
    <tradeName>D-ECH05090077V</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0509007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:37.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05080077N</udiDi>
    <basicUdiDi>B-ECH05080077N</basicUdiDi>
    <tradeName>D-ECH05080077N</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0508007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:35.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05070077F</udiDi>
    <basicUdiDi>B-ECH05070077F</basicUdiDi>
    <tradeName>D-ECH05070077F</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0507007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:31.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH050600778</udiDi>
    <basicUdiDi>B-ECH050600778</basicUdiDi>
    <tradeName>D-ECH050600778</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0506007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:09.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05050076Z</udiDi>
    <basicUdiDi>B-ECH05050076Z</basicUdiDi>
    <tradeName>D-ECH05050076Z</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0505007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:45:35.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05040076S</udiDi>
    <basicUdiDi>B-ECH05040076S</basicUdiDi>
    <tradeName>D-ECH05040076S</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0504007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:45:04.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05030076K</udiDi>
    <basicUdiDi>B-ECH05030076K</basicUdiDi>
    <tradeName>D-ECH05030076K</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0503007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:44:20.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05020076C</udiDi>
    <basicUdiDi>B-ECH05020076C</basicUdiDi>
    <tradeName>D-ECH05020076C</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0502007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:34.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH050100765</udiDi>
    <basicUdiDi>B-ECH050100765</basicUdiDi>
    <tradeName>D-ECH050100765</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0501007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:45.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH010900769</udiDi>
    <basicUdiDi>B-ECH010900769</basicUdiDi>
    <tradeName>D-ECH010900769</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0109007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:15.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01050075D</udiDi>
    <basicUdiDi>B-ECH01050075D</basicUdiDi>
    <tradeName>D-ECH01050075D</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:12.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01010074H</udiDi>
    <basicUdiDi>B-ECH01010074H</basicUdiDi>
    <tradeName>D-ECH01010074H</tradeName>
    <deviceName>Prealbumin (PA)</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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:22.678Z</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>
</eudamedExport>