<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06925912723523</udiDi>
    <basicUdiDi>692591270053H6</basicUdiDi>
    <tradeName>iFlash-IA-2A</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>W0102060106</emdnCode>
    <emdnDescription>THYROSIN PHOSPHATASE IA2 ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89049G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:14.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912737971</udiDi>
    <basicUdiDi>692591270327HL</basicUdiDi>
    <tradeName>iFlash-GADA Ⅲ</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>W0102060105</emdnCode>
    <emdnDescription>GAD II ANTIBODIES AND OTHER ICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86368-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:11.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>16977565581149</udiDi>
    <basicUdiDi>B-16977565581149</basicUdiDi>
    <tradeName>HbA1c Rapid Quantitative Test</tradeName>
    <deviceName>HbA1c Rapid Quantitative Test</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060109</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1142</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:10:06.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>14562185400455</udiDi>
    <basicUdiDi>B-14562185400455</basicUdiDi>
    <tradeName>14562185400455</tradeName>
    <deviceName>CL AIA-PACK C-Peptide 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029232</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:07:09.601Z</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>14562185400363</udiDi>
    <basicUdiDi>B-14562185400363</basicUdiDi>
    <tradeName>14562185400363</tradeName>
    <deviceName>CL AIA-PACK C-Peptide 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029132</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:06:55.197Z</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>14560189213316</udiDi>
    <basicUdiDi>B-14560189213316</basicUdiDi>
    <tradeName>14560189213316</tradeName>
    <deviceName>ST AIA-PACK C-PeptideII</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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0025283</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:02:26.751Z</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>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>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>08435287148732</udiDi>
    <basicUdiDi>B-08435287148732</basicUdiDi>
    <tradeName>08435287148732</tradeName>
    <deviceName>ANTI-INSULIN ANTIBODIES (INS)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060199</emdnCode>
    <emdnDescription>DIABETES ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44873</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:51:29.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034049110842</udiDi>
    <basicUdiDi>B-08034049110842</basicUdiDi>
    <tradeName>08034049110842</tradeName>
    <deviceName>IA2</deviceName>
    <manufacturerName>Dia.Metra Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027206</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060106</emdnCode>
    <emdnDescription>THYROSIN PHOSPHATASE IA2 ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKO084</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:01:57.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034049110828</udiDi>
    <basicUdiDi>B-08034049110828</basicUdiDi>
    <tradeName>08034049110828</tradeName>
    <deviceName>Anti GAD</deviceName>
    <manufacturerName>Dia.Metra Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027206</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060105</emdnCode>
    <emdnDescription>GAD II ANTIBODIES AND OTHER ICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKO082</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:01:53.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034049110774</udiDi>
    <basicUdiDi>B-08034049110774</basicUdiDi>
    <tradeName>08034049110774</tradeName>
    <deviceName>C-Peptide ELISA</deviceName>
    <manufacturerName>Dia.Metra Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027206</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKO077</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:01:37.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640146270016</udiDi>
    <basicUdiDi>B-07640146270016</basicUdiDi>
    <tradeName>07640146270016</tradeName>
    <deviceName>TECO® Human Intact Proinsulin ELISA</deviceName>
    <manufacturerName>TECOmedical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000030341</manufacturerSrn>
    <authorisedRepresentativeName>EUROBIO SCIENTIFIC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000023178</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060107</emdnCode>
    <emdnDescription>PROINSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE1012</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:58:09.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350108630153</udiDi>
    <basicUdiDi>B-07350108630153</basicUdiDi>
    <tradeName>Mercodia Proinsulin ELISA</tradeName>
    <deviceName>Mercodia Proinsulin ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060107</emdnCode>
    <emdnDescription>PROINSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1118-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:14.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350108630122</udiDi>
    <basicUdiDi>B-07350108630122</basicUdiDi>
    <tradeName>Mercodia Glucagon ELISA</tradeName>
    <deviceName>Mercodia Glucagon ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060102</emdnCode>
    <emdnDescription>GLUCAGON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1271-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:12.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350108630092</udiDi>
    <basicUdiDi>B-07350108630092</basicUdiDi>
    <tradeName>Mercodia Ultrasensitive C-peptide ELISA</tradeName>
    <deviceName>Mercodia Ultrasensitive C-peptide ELISA</deviceName>
    <manufacturerName>Mercodia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000005175</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-1141-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:08.636Z</lastUpdated>
  </row>
</eudamedExport>