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    <basicUdiDi>B-00810173656979</basicUdiDi>
    <tradeName>Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method)</tradeName>
    <deviceName>Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2RET9A01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:48.405Z</lastUpdated>
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    <udiDi>00810173656986</udiDi>
    <basicUdiDi>B-00810173656986</basicUdiDi>
    <tradeName>Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)</tradeName>
    <deviceName>Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2RYT8A01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:46.798Z</lastUpdated>
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    <udiDi>00810173656948</udiDi>
    <basicUdiDi>B-00810173656948</basicUdiDi>
    <tradeName>Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)</tradeName>
    <deviceName>Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2HPV29A01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:29.118Z</lastUpdated>
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    <udiDi>00810173656931</udiDi>
    <basicUdiDi>B-00810173656931</basicUdiDi>
    <tradeName>Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)</tradeName>
    <deviceName>Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2HPV18A01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:28.045Z</lastUpdated>
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    <udiDi>07640158216101</udiDi>
    <basicUdiDi>7640158216100ZC</basicUdiDi>
    <tradeName>Aspergillus fumigatus IgG ELISA</tradeName>
    <deviceName>Aspergillus fumigatus IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:15.164Z</lastUpdated>
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  <row>
    <udiDi>07640158219201</udiDi>
    <basicUdiDi>764015821920029</basicUdiDi>
    <tradeName>Toxocara canis IgG ELISA</tradeName>
    <deviceName>Toxocara canis IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9200</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:15.042Z</lastUpdated>
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    <udiDi>07640158219256</udiDi>
    <basicUdiDi>76401582192502Q</basicUdiDi>
    <tradeName>Ascaris IgG ELISA</tradeName>
    <deviceName>Ascaris IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9250</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.972Z</lastUpdated>
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    <udiDi>07640158219300</udiDi>
    <basicUdiDi>76401582193002E</basicUdiDi>
    <tradeName>Echinococcus multilocularis (Em2- Em18) IgG ELISA</tradeName>
    <deviceName>Echinococcus multilocularis (Em2- Em18) IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050204</emdnCode>
    <emdnDescription>ECHINOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9300</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.886Z</lastUpdated>
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  <row>
    <udiDi>07640158219317</udiDi>
    <basicUdiDi>76401582193102H</basicUdiDi>
    <tradeName>Echinococcus multilocularis (Em18) IgG ELISA</tradeName>
    <deviceName>Echinococcus multilocularis (Em18) IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050204</emdnCode>
    <emdnDescription>ECHINOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9310</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.825Z</lastUpdated>
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  <row>
    <udiDi>07640158219355</udiDi>
    <basicUdiDi>76401582193502V</basicUdiDi>
    <tradeName>Echinococcus granulosus IgG ELISA</tradeName>
    <deviceName>Echinococcus granulosus IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050204</emdnCode>
    <emdnDescription>ECHINOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9350</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.760Z</lastUpdated>
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  <row>
    <udiDi>07640158219409</udiDi>
    <basicUdiDi>76401582194002K</basicUdiDi>
    <tradeName>Acanthocheilonema viteae IgG ELISA</tradeName>
    <deviceName>Acanthocheilonema viteae IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9400</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.694Z</lastUpdated>
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  <row>
    <udiDi>07640158219454</udiDi>
    <basicUdiDi>764015821945032</basicUdiDi>
    <tradeName>Strongyloïdes ratti IgG ELISA</tradeName>
    <deviceName>Strongyloides ratti IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9450</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640158219508</udiDi>
    <basicUdiDi>76401582195002Q</basicUdiDi>
    <tradeName>Leishmania infantum IgG ELISA</tradeName>
    <deviceName>Leishmania infantum IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050205</emdnCode>
    <emdnDescription>LEISHMANIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9500</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.568Z</lastUpdated>
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    <udiDi>07640158219553</udiDi>
    <basicUdiDi>764015821955037</basicUdiDi>
    <tradeName>Entamoeba histolytica IgG ELISA</tradeName>
    <deviceName>Entamoeba histolytica IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050201</emdnCode>
    <emdnDescription>ENTAMOEBA HISTOLYTICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9550</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.490Z</lastUpdated>
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    <udiDi>07640158219607</udiDi>
    <basicUdiDi>76401582196002V</basicUdiDi>
    <tradeName>Schistosoma mansoni IgG ELISA</tradeName>
    <deviceName>Schistosoma mansoni IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050206</emdnCode>
    <emdnDescription>SCHISTOSOMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.416Z</lastUpdated>
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    <udiDi>07640158219652</udiDi>
    <basicUdiDi>76401582196503C</basicUdiDi>
    <tradeName>Fasciola hepatica IgG ELISA</tradeName>
    <deviceName>Fasciola hepatica IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050203</emdnCode>
    <emdnDescription>DISTOMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9650</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.360Z</lastUpdated>
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    <udiDi>07640158219706</udiDi>
    <basicUdiDi>764015821970032</basicUdiDi>
    <tradeName>Taenia solium IgG ELISA</tradeName>
    <deviceName>Taenia solium IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9700</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.313Z</lastUpdated>
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    <udiDi>07640158219751</udiDi>
    <basicUdiDi>76401582197503H</basicUdiDi>
    <tradeName>Trichinella spiralis IgG ELISA</tradeName>
    <deviceName>Trichinella spiralis IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9750</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.259Z</lastUpdated>
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    <udiDi>07640158219805</udiDi>
    <basicUdiDi>764015821980037</basicUdiDi>
    <tradeName>Anisakidae IgG ELISA</tradeName>
    <deviceName>Anisakidae IgG ELISA</deviceName>
    <manufacturerName>Bordier Affinity Products SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025247</manufacturerSrn>
    <authorisedRepresentativeName>Leman Diagnostics SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000024185</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9800</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:28:14.126Z</lastUpdated>
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    <udiDi>00686597202173</udiDi>
    <basicUdiDi>B-00686597202173</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName>INSTI HIV Ab CE iten 50 and INSTI HIV Ab CE iten 350</deviceName>
    <manufacturerName>bioLytical Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023304</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1015-017 and 90-1015-018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:04:06.438Z</lastUpdated>
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