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<eudamedExport entity="devices">
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    <basicUdiDi>69257945W0102050109R0NV</basicUdiDi>
    <tradeName>Human Sex Hormone-binding Globulin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Human Sex Hormone-binding Globulin Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050109</emdnCode>
    <emdnDescription>SEX HORMONE BINDING GLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013889</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:28:23.358Z</lastUpdated>
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    <udiDi>06925794588562</udiDi>
    <basicUdiDi>69257945W0102039001R0PV</basicUdiDi>
    <tradeName>Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013790</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:28:18.383Z</lastUpdated>
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    <udiDi>06925794588449</udiDi>
    <basicUdiDi>69257945W01020401R0XW</basicUdiDi>
    <tradeName>Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013860</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:28:17.583Z</lastUpdated>
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    <udiDi>06925794588302</udiDi>
    <basicUdiDi>69257945W0102030103R0LV</basicUdiDi>
    <tradeName>Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013798</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:28:16.787Z</lastUpdated>
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  <row>
    <udiDi>06925794577412</udiDi>
    <basicUdiDi>69257945W01029099R05H</basicUdiDi>
    <tradeName>Probe Washing Buffer</tradeName>
    <deviceName>Chemiluminescence Immunoassay Reagent</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019952</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:28:06.368Z</lastUpdated>
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    <udiDi>06925794524553</udiDi>
    <basicUdiDi>69257945W01029003R02L</basicUdiDi>
    <tradeName>Sample Pretreatment Reagent</tradeName>
    <deviceName>Chemiluminescence Immunoassay Reagent</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016190</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:27:59.971Z</lastUpdated>
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    <udiDi>06924030416409</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Cardiolipin IgA</tradeName>
    <deviceName>BioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set</deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02197C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:37.533Z</lastUpdated>
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    <udiDi>06924030405199</udiDi>
    <basicUdiDi>6924030BioCLIACR4E</basicUdiDi>
    <tradeName>BioCLIA System Wash Buffer</tradeName>
    <deviceName>BioCLIA Sample Diluent I,BioCLIA System Wash Buffer,BioCLIA System Substrate</deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:34.334Z</lastUpdated>
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    <udiDi>16438153812507</udiDi>
    <basicUdiDi>6438153BU00169CA</basicUdiDi>
    <tradeName>SpeciTrol</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981250</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:02:38.348Z</lastUpdated>
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    <udiDi>16438153000812</udiDi>
    <basicUdiDi>6438153BU00123BJ</basicUdiDi>
    <tradeName>Ferritin Control High</tradeName>
    <deviceName>Ferritin Control High</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981876</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:02:23.089Z</lastUpdated>
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    <udiDi>16438153000737</udiDi>
    <basicUdiDi>6438153BU00120BC</basicUdiDi>
    <tradeName>sTfR Control High</tradeName>
    <deviceName>sTfR Control High</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981867</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:02:04.630Z</lastUpdated>
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    <udiDi>16438153000720</udiDi>
    <basicUdiDi>6438153BU00119BT</basicUdiDi>
    <tradeName>sTfR Control</tradeName>
    <deviceName>sTfR Control</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981866</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:02:03.841Z</lastUpdated>
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    <udiDi>16438153000706</udiDi>
    <basicUdiDi>6438153BU00124BL</basicUdiDi>
    <tradeName>sTfR</tradeName>
    <deviceName>sTfR</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070104</emdnCode>
    <emdnDescription>SOLUBLE TRANSFERRIN RECEPTOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981945</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:02:03.343Z</lastUpdated>
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    <udiDi>06260001187177</udiDi>
    <basicUdiDi>62600011ATK.TSH5N</basicUdiDi>
    <tradeName>ATK TSH</tradeName>
    <deviceName>TSH ELISA Kit</deviceName>
    <manufacturerName>Arghavan Teb Kavian</manufacturerName>
    <manufacturerSrn>IR-MF-000045430</manufacturerSrn>
    <authorisedRepresentativeName>Medisol Technologies S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000044726</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATK.R031</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:31:20.617Z</lastUpdated>
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    <udiDi>06260001187139</udiDi>
    <basicUdiDi>62600011ATK.VITDAB</basicUdiDi>
    <tradeName>ATK Vit D</tradeName>
    <deviceName>25-OH Vitamin D ELISA kit</deviceName>
    <manufacturerName>Arghavan Teb Kavian</manufacturerName>
    <manufacturerSrn>IR-MF-000045430</manufacturerSrn>
    <authorisedRepresentativeName>Medisol Technologies S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000044726</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATK.E071</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:31:19.026Z</lastUpdated>
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    <udiDi>05999862454005</udiDi>
    <basicUdiDi>599986245415L</basicUdiDi>
    <tradeName>Theresa RUO Kit</tradeName>
    <deviceName>Theresa RUO kit</deviceName>
    <manufacturerName>Navolab Diagnosztika Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025337</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102109099</emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK-0001</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:41.288Z</lastUpdated>
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    <udiDi>05999862177096</udiDi>
    <basicUdiDi>5999862177300138B</basicUdiDi>
    <tradeName>HISTOLS Peroxidáz gátló oldat</tradeName>
    <deviceName>HISTOLS Peroxidáz gátló oldat</deviceName>
    <manufacturerName>Hisztopatológia Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000014417</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30013</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:45:18.113Z</lastUpdated>
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    <udiDi>05999862177089</udiDi>
    <basicUdiDi>59998621773001289</basicUdiDi>
    <tradeName>HISTOLS BBPS Háttér gátló oldat</tradeName>
    <deviceName>HISTOLS BBPS Háttér gátló oldat</deviceName>
    <manufacturerName>Hisztopatológia Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000014417</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30012</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:45:17.321Z</lastUpdated>
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    <udiDi>05999862177072</udiDi>
    <basicUdiDi>59998621773001085</basicUdiDi>
    <tradeName>HISTOLS Citrát puffer</tradeName>
    <deviceName>HISTOLS Citrát puffer</deviceName>
    <manufacturerName>Hisztopatológia Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000014417</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30010</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:45:16.514Z</lastUpdated>
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    <udiDi>05999862177034</udiDi>
    <basicUdiDi>599986217730011MRTHR</basicUdiDi>
    <tradeName>HISTOLS-MR-T</tradeName>
    <deviceName>HISTOLS-MR-T</deviceName>
    <manufacturerName>Hisztopatológia Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000014417</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30011.500T</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:45:10.912Z</lastUpdated>
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