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<eudamedExport entity="devices">
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    <basicUdiDi>B-00894175000985</basicUdiDi>
    <tradeName>AccuDiag™ Vitamin B12  ELISA</tradeName>
    <deviceName>AccuDiag™ Vitamin B12  ELISA</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3125-15</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:22.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894175000534</udiDi>
    <basicUdiDi>B-00894175000534</basicUdiDi>
    <tradeName>AccuDiag™ Ferritin ELISA</tradeName>
    <deviceName>AccuDiag™ Ferritin ELISA</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1601-18</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:18.031Z</lastUpdated>
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  <row>
    <udiDi>00894175000473</udiDi>
    <basicUdiDi>B-00894175000473</basicUdiDi>
    <tradeName>AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA</tradeName>
    <deviceName>AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070104</emdnCode>
    <emdnDescription>SOLUBLE TRANSFERRIN RECEPTOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3126-15</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:17.230Z</lastUpdated>
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  <row>
    <udiDi>00850054026477</udiDi>
    <basicUdiDi>B-00850054026477</basicUdiDi>
    <tradeName>AccuDiagTM Total Human IgE</tradeName>
    <deviceName>Total Human IgE ELISA Kit</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1801-18</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:21.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850049545655</udiDi>
    <basicUdiDi>B-00850049545655</basicUdiDi>
    <tradeName>AccuDiag™ Human Specific IgE  (20 Perennial Allergens)</tradeName>
    <deviceName>AccuDiag™ Human Specific IgE  (20 Perennial Allergens)</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5253-8</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:14.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850049545648</udiDi>
    <basicUdiDi>B-00850049545648</basicUdiDi>
    <tradeName>AccuDiag™ Human Specific IgE (20 Atopic Allergens)</tradeName>
    <deviceName>AccuDiag™ Human Specific IgE (20 Atopic Allergens)</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5151-8</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:10.523Z</lastUpdated>
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  <row>
    <udiDi>00850049545204</udiDi>
    <basicUdiDi>B-00850049545204</basicUdiDi>
    <tradeName>AccuDiag™ Human Specific IgE  (20 Food Allergens)</tradeName>
    <deviceName>AccuDiag™ Human Specific IgE  (20 Food Allergens)</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5152-8</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:09.716Z</lastUpdated>
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  <row>
    <udiDi>00850049545006</udiDi>
    <basicUdiDi>B-00850049545006</basicUdiDi>
    <tradeName>AccuDiag™ Folate  ELISA</tradeName>
    <deviceName>AccuDiag™ Folate  ELISA</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3127-15</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:08.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AB5150ZR445Q</udiDi>
    <basicUdiDi>B-AB5150ZR445Q</basicUdiDi>
    <tradeName>AccuDiag™ Human Specific IgE (20 Seasonal Allergens)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5150-8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:17.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AL5154ZR44EA</udiDi>
    <basicUdiDi>B-AL5154ZR44EA</basicUdiDi>
    <tradeName>AccuDiag™ Human Specific IgG 88 Food Allergens</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5154-8</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:33:04.812Z</lastUpdated>
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