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<eudamedExport entity="devices">
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    <basicUdiDi>B-10811877011177</basicUdiDi>
    <tradeName>BinaxNOW™ RSV Card (22T)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>430-022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:24.295Z</lastUpdated>
  </row>
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    <udiDi>10811877011047</udiDi>
    <basicUdiDi>B-10811877011047</basicUdiDi>
    <tradeName>BinaxNOW™ Legionella Urinary Antigen Card (22T)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:12.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010354</udiDi>
    <basicUdiDi>B-10811877010354</basicUdiDi>
    <tradeName>BinaxNOW™ Malaria (25T)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>660-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:12.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010989</udiDi>
    <basicUdiDi>B-10811877010989</basicUdiDi>
    <tradeName>BinaxNOW™ Influenza A &amp; B Card 2 Control Swab Kit (10 POS+10 NEG)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>575-080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:11.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011160</udiDi>
    <basicUdiDi>B-10811877011160</basicUdiDi>
    <tradeName>BinaxNOW™ RSV Card (42T)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>430-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:11.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011085</udiDi>
    <basicUdiDi>B-10811877011085</basicUdiDi>
    <tradeName>BinaxNOW™ Streptococcus pneumoniae Antigen Card (22T)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:11.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010927</udiDi>
    <basicUdiDi>B-10811877010927</basicUdiDi>
    <tradeName>BinaxNOW™ Strep A Card (25T)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>735-025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:11.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010712</udiDi>
    <basicUdiDi>B-10811877010712</basicUdiDi>
    <tradeName>BinaxNOW™ Malaria Positive Control Kit (10)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>665-010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:11.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010033</udiDi>
    <basicUdiDi>B-10811877010033</basicUdiDi>
    <tradeName>BinaxNOW™ Malaria</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:11.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011030</udiDi>
    <basicUdiDi>B-10811877011030</basicUdiDi>
    <tradeName>BinaxNOW™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852-012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T03:54:26.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010460</udiDi>
    <basicUdiDi>B-10811877010460</basicUdiDi>
    <tradeName>Binax™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>851-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-01T19:46:27.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011054</udiDi>
    <basicUdiDi>B-10811877011054</basicUdiDi>
    <tradeName>BinaxNOW™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>852-010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-01T19:46:27.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010705</udiDi>
    <basicUdiDi>B-10811877010705</basicUdiDi>
    <tradeName>BinaxNOW™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>780-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-01T19:46:27.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010767</udiDi>
    <basicUdiDi>B-10811877010767</basicUdiDi>
    <tradeName>Binax™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abbott Diagnostics Scarborough, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014444</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>851-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-01T19:46:27.218Z</lastUpdated>
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