<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974671101530</udiDi>
    <basicUdiDi>B-06974671101530</basicUdiDi>
    <tradeName>06974671101530</tradeName>
    <deviceName>Quantitative Diagnostic Kit for Neonatal Thyroid Stimulating Hormone (TRFIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-NS-A001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:09:10.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430002471778</udiDi>
    <basicUdiDi>B-05430002471778</basicUdiDi>
    <tradeName>NEONATAL TSH Screening ELISA</tradeName>
    <deviceName>NEONATAL TSH Screening ELISA</deviceName>
    <manufacturerName>LaCAR MDx Technologies</manufacturerName>
    <manufacturerSrn>BE-MF-000001212</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-GP-576</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:38.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590759</udiDi>
    <basicUdiDi>697518250F125022C</basicUdiDi>
    <tradeName>Thyrotropin CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Thyrotropin CLIA Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F12102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:30:20.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147413157</udiDi>
    <basicUdiDi>B-06438147413157</basicUdiDi>
    <tradeName>DELFIA Neonatal hTSH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A032-303</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:37:57.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147140473</udiDi>
    <basicUdiDi>B-06438147140473</basicUdiDi>
    <tradeName>AutoDELFIA Neonatal hTSH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B032-312</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:34:49.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147140466</udiDi>
    <basicUdiDi>B-06438147140466</basicUdiDi>
    <tradeName>DELFIA Neonatal hTSH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A032-310</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:34:47.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147009213</udiDi>
    <basicUdiDi>B-06438147009213</basicUdiDi>
    <tradeName>DELFIA Neonatal hTSH Ultra kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020403</emdnCode>
    <emdnDescription>NEONATAL THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A042-201</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:34:21.608Z</lastUpdated>
  </row>
</eudamedExport>