<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-35174</udiDi>
    <basicUdiDi>B-35174</basicUdiDi>
    <tradeName>D-35174</tradeName>
    <deviceName>Pepsinogen I 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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:00.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3500AD</udiDi>
    <basicUdiDi>B-3500AD</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep®  Complete Kit for VMA, HVA, 5-HIAA in Urine, advanced</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060699</emdnCode>
    <emdnDescription>MULTIPLE INDIVIDUAL HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:36:33.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3326Y</udiDi>
    <basicUdiDi>B-3326Y</basicUdiDi>
    <tradeName>D-3326Y</tradeName>
    <deviceName>Procalcitonin 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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:25.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-31978</udiDi>
    <basicUdiDi>B-31978</basicUdiDi>
    <tradeName>D-31978</tradeName>
    <deviceName>Connecting Peptide 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:18:01.514Z</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>D-3068AN</udiDi>
    <basicUdiDi>B-3068AN</basicUdiDi>
    <tradeName>D-3068AN</tradeName>
    <deviceName>C-Peptide 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>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AKBR3068030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:16:30.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3057AH</udiDi>
    <basicUdiDi>B-3057AH</basicUdiDi>
    <tradeName>D-3057AH</tradeName>
    <deviceName>PTH 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>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AKBR3057030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:08:19.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3025A4</udiDi>
    <basicUdiDi>B-3025A4</basicUdiDi>
    <tradeName>D-3025A4</tradeName>
    <deviceName>25-OH-Vitamin D 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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AKBR3025030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:07:29.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30009L</udiDi>
    <basicUdiDi>B-30009L</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep®  Complete Kit for VMA, HVA, 5-HIAA in Urine</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060699</emdnCode>
    <emdnDescription>MULTIPLE INDIVIDUAL HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:07:02.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-25-OHVD706-AESU</udiDi>
    <basicUdiDi>B-25-OHVD706-AESU</basicUdiDi>
    <tradeName>25-OH Vitamin D Total (CLIA)</tradeName>
    <deviceName>25-OH Vitamin D Total (CLIA)</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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-OHVD706-AE10Y, 25-OHVD706-AE10N, 25-OHVD706-AE20Y, 25-OHVD706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:47:32.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2200BAMIDZ</udiDi>
    <basicUdiDi>B-2200BAMIDZ</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep®  Complete Kit for Catecholamines in Urine (automated sample preparation with Gilson® ASPECTM)</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>2200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:27:44.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850076346434</udiDi>
    <basicUdiDi>B-20850076346434</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>2026-07-11T12:03:32.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850076346427</udiDi>
    <basicUdiDi>B-20850076346427</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>2026-07-11T12:03:31.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850076346410</udiDi>
    <basicUdiDi>B-20850076346410</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>2026-07-11T12:03:27.852Z</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>20850076346359</udiDi>
    <basicUdiDi>B-20850076346359</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>2026-07-11T12:03:19.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850076346106</udiDi>
    <basicUdiDi>B-20850076346106</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>2026-07-11T12:02:27.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2000BAMICX</udiDi>
    <basicUdiDi>B-2000BAMICX</basicUdiDi>
    <tradeName>ClinRep®</tradeName>
    <deviceName>ClinRep® Complete Kit for Catecholamines in Urine</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>2000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:21.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719427</udiDi>
    <basicUdiDi>692591270157HK</basicUdiDi>
    <tradeName>iFlash-Gastrin-17</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>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86055-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:12.366Z</lastUpdated>
  </row>
</eudamedExport>