<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DC76348G6</udiDi>
    <basicUdiDi>B-DC76348G6</basicUdiDi>
    <tradeName>iStar-Insulin</tradeName>
    <deviceName>iStar-Insulin</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76348</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:12:36.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76097G4</udiDi>
    <basicUdiDi>B-DC76097G4</basicUdiDi>
    <tradeName>iStar-Insulin</tradeName>
    <deviceName>iStar-Insulin</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76097</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:04:36.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7F01DT</udiDi>
    <basicUdiDi>B-7F01DT</basicUdiDi>
    <tradeName>Insulin assay (CLIA)</tradeName>
    <deviceName>Insulin assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7F01V1-B-EU, 7F01U1-B-EU, 7F01P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:16.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-31876</udiDi>
    <basicUdiDi>B-31876</basicUdiDi>
    <tradeName>D-31876</tradeName>
    <deviceName>Insulin Quantitative Detection KIT (Chemiluminescent Immunoassay)</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>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:18:00.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3069AQ</udiDi>
    <basicUdiDi>B-3069AQ</basicUdiDi>
    <tradeName>D-3069AQ</tradeName>
    <deviceName>Insulin in vitro diagnostic kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Aikang Diagnostics Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028962</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AKBR3069030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:16:32.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850076346366</udiDi>
    <basicUdiDi>B-20850076346366</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>2026-07-11T12:03:20.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723431</udiDi>
    <basicUdiDi>692591270047HB</basicUdiDi>
    <tradeName>iFlash-Insulin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86036-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:14.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185400448</udiDi>
    <basicUdiDi>B-14562185400448</basicUdiDi>
    <tradeName>14562185400448</tradeName>
    <deviceName>CL AIA-PACK IRI ADJUSTER SET</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>0029231</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:07:08.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185400356</udiDi>
    <basicUdiDi>B-14562185400356</basicUdiDi>
    <tradeName>14562185400356</tradeName>
    <deviceName>CL AIA-PACK IRI TEST CUP</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>0029131</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:06:54.386Z</lastUpdated>
  </row>
  <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>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>08684595030226</udiDi>
    <basicUdiDi>B-08684595030226</basicUdiDi>
    <tradeName>RapidFor™ Insulin Rapid Test Kit (FIA)</tradeName>
    <deviceName>Insulin Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO85</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:13:09.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350108630061</udiDi>
    <basicUdiDi>B-07350108630061</basicUdiDi>
    <tradeName>Mercodia Ultrasensitive Insulin ELISA</tradeName>
    <deviceName>Mercodia Ultrasensitive Insulin ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1132-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:07.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350108630054</udiDi>
    <basicUdiDi>B-07350108630054</basicUdiDi>
    <tradeName>Mercodia Iso-Insulin ELISA</tradeName>
    <deviceName>Mercodia Iso-Insulin ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1128-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:05.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350108630030</udiDi>
    <basicUdiDi>B-07350108630030</basicUdiDi>
    <tradeName>Mercodia Insulin ELISA – 10 pack</tradeName>
    <deviceName>Mercodia Insulin ELISA – 10 pack</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1113-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:01.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350108630023</udiDi>
    <basicUdiDi>B-07350108630023</basicUdiDi>
    <tradeName>Mercodia Insulin ELISA</tradeName>
    <deviceName>Mercodia Insulin ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1113-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:00.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139071366</udiDi>
    <basicUdiDi>B-06978139071366</basicUdiDi>
    <tradeName>Insulin Test (FIA)</tradeName>
    <deviceName>Insulin Test (FIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320307702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:09.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753472330</udiDi>
    <basicUdiDi>B-06976753472330</basicUdiDi>
    <tradeName>Insulin (INS) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</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>C2KN002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:57:49.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063270</udiDi>
    <basicUdiDi>B-06975984063270</basicUdiDi>
    <tradeName>Insulin (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName>Insulin (Electrochemiluminescence Immunoassay)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>695025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:18:24.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975388110013</udiDi>
    <basicUdiDi>B-06975388110013</basicUdiDi>
    <tradeName>06975388110013</tradeName>
    <deviceName>Insulin Test Kit(Dry Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Lansion Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001086</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0AJ6-03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:30:27.523Z</lastUpdated>
  </row>
</eudamedExport>