<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>14560189210414</udiDi>
    <basicUdiDi>B-14560189210414</basicUdiDi>
    <tradeName>14560189210414</tradeName>
    <deviceName>ST AIA-PACK IRI</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0025260</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:01:27.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-12M87</udiDi>
    <basicUdiDi>B-12M87</basicUdiDi>
    <tradeName>D-12M87</tradeName>
    <deviceName>25-Hydroxyvitamin D Assay Kit (Latex Immunoturbidimetric 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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:56:58.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1280MMELLD</udiDi>
    <basicUdiDi>B-1280MMELLD</basicUdiDi>
    <tradeName>Melatonin Reagent Set</tradeName>
    <deviceName>Melatonine Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069003</emdnCode>
    <emdnDescription>MELATONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1280 M MEL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:56:08.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11Q8C</udiDi>
    <basicUdiDi>B-11Q8C</basicUdiDi>
    <tradeName>D-11Q8C</tradeName>
    <deviceName>Pepsinogens ⅡAssay Kit (Latex Immunoturbidimetric 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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:48.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11P8A</udiDi>
    <basicUdiDi>B-11P8A</basicUdiDi>
    <tradeName>D-11P8A</tradeName>
    <deviceName>PepsinogensⅠAssay Kit (Latex Immunoturbidimetric 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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:43.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11J7W</udiDi>
    <basicUdiDi>B-11J7W</basicUdiDi>
    <tradeName>D-11J7W</tradeName>
    <deviceName>Neutrophil Gelatinase-Associated Lipocalin Assay Kit (Latex Immunoturbidimetric 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>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:25.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1180MCODS6K</udiDi>
    <basicUdiDi>B-1180MCODS6K</basicUdiDi>
    <tradeName>Cortisol &amp; Cortisone Dilute &amp; Shoot Reagent Set</tradeName>
    <deviceName>Cortisone &amp; Cortisol Dilute &amp; Shoot Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1180 M CODS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:10.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1155Q-25DB</udiDi>
    <basicUdiDi>B-1155Q-25DB</basicUdiDi>
    <tradeName>Rapi-D™ Quantitative Vitamin D Test</tradeName>
    <deviceName>Rapi-D™ Quantitative Vitamin D Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1155Q-25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:51:20.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1100MSTPK7</udiDi>
    <basicUdiDi>B-1100MSTPK7</basicUdiDi>
    <tradeName>Steroid Basic Panel Reagent Set</tradeName>
    <deviceName>Steroid Basic Panel Reagent Set</deviceName>
    <manufacturerName>Diagnotix B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000236</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100 M STP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:47:09.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850076346437</udiDi>
    <basicUdiDi>B-10850076346437</basicUdiDi>
    <tradeName>Parathyroid Hormone Test Kit (CLIA)</tradeName>
    <deviceName>Parathyroid Hormone Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIPTH-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:40:05.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850076346420</udiDi>
    <basicUdiDi>B-10850076346420</basicUdiDi>
    <tradeName>N-MID Osteocalcin Test Kit (CLIA)</tradeName>
    <deviceName>N-MID Osteocalcin Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIMID(N)-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:40:04.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850076346413</udiDi>
    <basicUdiDi>B-10850076346413</basicUdiDi>
    <tradeName>25-OH-Vitamin D Test Kit (CLIA)</tradeName>
    <deviceName>25-OH-Vitamin D Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIVD-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:40:03.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850076346369</udiDi>
    <basicUdiDi>B-10850076346369</basicUdiDi>
    <tradeName>Insulin Test Kit (CLIA)</tradeName>
    <deviceName>Insulin Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIINS-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:39:56.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850076346352</udiDi>
    <basicUdiDi>B-10850076346352</basicUdiDi>
    <tradeName>C-Peptide Test Kit (CLIA)</tradeName>
    <deviceName>C-Peptide Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIPEP(C)-201a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:39:52.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850076346109</udiDi>
    <basicUdiDi>B-10850076346109</basicUdiDi>
    <tradeName>Procalcitonin Test Kit (CLIA)</tradeName>
    <deviceName>Procalcitonin Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDPCT-401a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:57.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1000BAMICC</udiDi>
    <basicUdiDi>B-1000BAMICC</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Catecholamines in Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060601</emdnCode>
    <emdnDescription>ADRENALIN / NORADRENALINE / DOPAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:21.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067155</udiDi>
    <basicUdiDi>69703416803205109JJ</basicUdiDi>
    <tradeName>Renin (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060204</emdnCode>
    <emdnDescription>RENINE (PLASMA RENINE ACTIVITY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:56:03.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067179</udiDi>
    <basicUdiDi>69703416803205109JJ</basicUdiDi>
    <tradeName>Renin (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060204</emdnCode>
    <emdnDescription>RENINE (PLASMA RENINE ACTIVITY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511902</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:55:54.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067162</udiDi>
    <basicUdiDi>69703416803205109JJ</basicUdiDi>
    <tradeName>Renin (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060204</emdnCode>
    <emdnDescription>RENINE (PLASMA RENINE ACTIVITY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320511904</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:55:51.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984064079</udiDi>
    <basicUdiDi>69703416803205106JC</basicUdiDi>
    <tradeName>IGFBP-3 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:53:35.848Z</lastUpdated>
  </row>
</eudamedExport>