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<eudamedExport entity="devices">
  <row>
    <udiDi>10811877010972</udiDi>
    <basicUdiDi>B-10811877010972</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>575-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:07:24.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011153</udiDi>
    <basicUdiDi>B-10811877011153</basicUdiDi>
    <tradeName>BinaxNOW™ Influenza A &amp; B Card Control Swab Kit</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>416-080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:07:12.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811877011552</udiDi>
    <basicUdiDi>B-00811877011552</basicUdiDi>
    <tradeName>NMP22™ BladderChek™ Control Kit (1 POS+1 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>Piyasada</deviceStatus>
    <reference>D1250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:07:06.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811877011569</udiDi>
    <basicUdiDi>B-00811877011569</basicUdiDi>
    <tradeName>NMP22™ BladderChek™ Test (10T)</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>D1300E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:07:05.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811877011545</udiDi>
    <basicUdiDi>B-00811877011545</basicUdiDi>
    <tradeName>NMP22™ BladderChek™ Test (24T)</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>D1200E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:06:48.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010552</udiDi>
    <basicUdiDi>B-10811877010552</basicUdiDi>
    <tradeName>ID NOW™ Strep A 2 (24T)</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>734-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:06:19.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010538</udiDi>
    <basicUdiDi>B-10811877010538</basicUdiDi>
    <tradeName>ID NOW™ RSV Control Swab Kit (12 POS+12 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>Piyasada</deviceStatus>
    <reference>435-080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:06:14.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010521</udiDi>
    <basicUdiDi>B-10811877010521</basicUdiDi>
    <tradeName>ID NOW™ RSV (24T)</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>435-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:06:03.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010422</udiDi>
    <basicUdiDi>B-10811877010422</basicUdiDi>
    <tradeName>ID NOW™ Influenza A &amp; B 2 (24T)</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>427-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:06:03.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011146</udiDi>
    <basicUdiDi>B-10811877011146</basicUdiDi>
    <tradeName>BinaxNOW™ Influenza A &amp; B Card</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>416-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:06:01.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011221</udiDi>
    <basicUdiDi>B-10811877011221</basicUdiDi>
    <tradeName>ID NOW™ Influenza A &amp; B 2 Control Swab Kit (12 POS+12 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>Piyasada</deviceStatus>
    <reference>425-080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:06:00.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811877011361</udiDi>
    <basicUdiDi>B-00811877011361</basicUdiDi>
    <tradeName>ID NOW™ COVID-19 2.0 Control Swab Kit (12 POS+12 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>Piyasada</deviceStatus>
    <reference>192-080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:05:59.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011252</udiDi>
    <basicUdiDi>B-10811877011252</basicUdiDi>
    <tradeName>Determine™ TB LAM Ag (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>7D2741</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:05:46.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011238</udiDi>
    <basicUdiDi>B-10811877011238</basicUdiDi>
    <tradeName>Clearview™ PBP2a SA Culture Colony Test (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>893-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:05:25.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>00811877011286</udiDi>
    <basicUdiDi>B-00811877011286</basicUdiDi>
    <tradeName>Bioline Filariasis Test Strip (30T)</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>625-000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:05:24.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011078</udiDi>
    <basicUdiDi>B-10811877011078</basicUdiDi>
    <tradeName>BinaxNOW™ Streptococcus pneumoniae Antigen Card (12T)</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>710-012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:05:05.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011092</udiDi>
    <basicUdiDi>B-10811877011092</basicUdiDi>
    <tradeName>BinaxNOW™ Streptococcus pneumoniae Control Swab Pack (5 POS+5 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>Piyasada</deviceStatus>
    <reference>710-010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:56.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010446</udiDi>
    <basicUdiDi>B-10811877010446</basicUdiDi>
    <tradeName>BinaxNOW™ Strep A Control Swab Kit (5 POS+5 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>Piyasada</deviceStatus>
    <reference>730-010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:27.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877011207</udiDi>
    <basicUdiDi>B-10811877011207</basicUdiDi>
    <tradeName>BinaxNOW™ RSV 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>Piyasada</deviceStatus>
    <reference>430-080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:26.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>10811877010484</udiDi>
    <basicUdiDi>B-10811877010484</basicUdiDi>
    <tradeName>BinaxNOW™ Nasopharyngeal Swab Accessory Kit (22 NPSWB)</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>400-065</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-02T20:04:24.323Z</lastUpdated>
  </row>
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