<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-8012992BGMSCketAX2CA</udiDi>
    <basicUdiDi>B-8012992BGMSCketAX2CA</basicUdiDi>
    <tradeName>GLUCOFIX TECH  B-Ketone Control</tradeName>
    <deviceName>GLUCOFIX TECH  B-Ketone Control</deviceName>
    <manufacturerName>A. MENARINI Diagnostics S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000023427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48591 (IT/FR/NL), 48592 (IT/FR/NL), 61555  (UK),  61556 (UK)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:02.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSCketAXKU</udiDi>
    <basicUdiDi>B-8012992BGMSCketAXKU</basicUdiDi>
    <tradeName>GlucoMen areo B-Ketone Control</tradeName>
    <deviceName>GlucoMen areo B-Ketone Control</deviceName>
    <manufacturerName>A. MENARINI Diagnostics S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000023427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47957,48375,48302,48375,47958,48376,48303,47958,48376</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:02.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSCgluB2HX</udiDi>
    <basicUdiDi>B-8012992BGMSCgluB2HX</basicUdiDi>
    <tradeName>GlucoMen areo Control</tradeName>
    <deviceName>GlucoMen areo Control</deviceName>
    <manufacturerName>A. MENARINI Diagnostics S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000023427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>46197,46199,46201,47954,46198,46200,46202,47955</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:02.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSCgluB229Y</udiDi>
    <basicUdiDi>B-8012992BGMSCgluB229Y</basicUdiDi>
    <tradeName>GLUCOFIX TECH Control</tradeName>
    <deviceName>GLUCOFIX TECH Control</deviceName>
    <manufacturerName>A. MENARINI Diagnostics S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000023427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>47686 FR/NL, 46630 FR/NL/IT/UK, 47687 FR/NL, 46631, FR/NL/IT/UK</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:29:58.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-800003712JG</udiDi>
    <basicUdiDi>B-800003712JG</basicUdiDi>
    <tradeName>Agamatrix Jazz Test Strips</tradeName>
    <deviceName>Agamatrix Jazz Test Strips 50ct</deviceName>
    <manufacturerName>AgaMatrix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000039145</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800003712</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:29:16.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78730JX</udiDi>
    <basicUdiDi>B-78730JX</basicUdiDi>
    <tradeName>GLUCOCARD X-sensor</tradeName>
    <deviceName>GLUCOCARD X-sensor</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78730</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:56.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78728KC</udiDi>
    <basicUdiDi>B-78728KC</basicUdiDi>
    <tradeName>GLUCOCARD X-sensor</tradeName>
    <deviceName>GLUCOCARD X-sensor</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78728</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:39.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78727KA</udiDi>
    <basicUdiDi>B-78727KA</basicUdiDi>
    <tradeName>GLUCOCARD X-sensor</tradeName>
    <deviceName>GLUCOCARD X-sensor</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78727</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:37.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78726K8</udiDi>
    <basicUdiDi>B-78726K8</basicUdiDi>
    <tradeName>GLUCOCARD X-sensor</tradeName>
    <deviceName>GLUCOCARD X-sensor</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78726</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:35.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78724K4</udiDi>
    <basicUdiDi>B-78724K4</basicUdiDi>
    <tradeName>GLUCOCARD X-sensor</tradeName>
    <deviceName>GLUCOCARD X-sensor</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78724</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:34.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78723K2</udiDi>
    <basicUdiDi>B-78723K2</basicUdiDi>
    <tradeName>GLUCOCARD X-sensor</tradeName>
    <deviceName>GLUCOCARD X-sensor</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78723</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:34.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78722JY</udiDi>
    <basicUdiDi>B-78722JY</basicUdiDi>
    <tradeName>GLUCOCARD X-sensor</tradeName>
    <deviceName>GLUCOCARD X-sensor</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78722</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:31.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78711JT</udiDi>
    <basicUdiDi>B-78711JT</basicUdiDi>
    <tradeName>GLUCOCARD X-sensor</tradeName>
    <deviceName>GLUCOCARD X-sensor</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78711</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:28.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78710JR</udiDi>
    <basicUdiDi>B-78710JR</basicUdiDi>
    <tradeName>GLUCOCARD X-sensor</tradeName>
    <deviceName>GLUCOCARD X-sensor</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78710</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:27.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78610JL</udiDi>
    <basicUdiDi>B-78610JL</basicUdiDi>
    <tradeName>GLUCOCARD 01 SENSOR</tradeName>
    <deviceName>GLUCOCARD 01 SENSOR</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78610</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:26.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78559KD</udiDi>
    <basicUdiDi>B-78559KD</basicUdiDi>
    <tradeName>GLUCOCARD 01 SENSOR</tradeName>
    <deviceName>GLUCOCARD 01 SENSOR</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78559</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:23.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78548K8</udiDi>
    <basicUdiDi>B-78548K8</basicUdiDi>
    <tradeName>GLUCOCARD 01 CONTROL</tradeName>
    <deviceName>GLUCOCARD 01 CONTROL</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78548</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:22.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78547K6</udiDi>
    <basicUdiDi>B-78547K6</basicUdiDi>
    <tradeName>GLUCOCARD 01 CONTROL</tradeName>
    <deviceName>GLUCOCARD 01 CONTROL</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78547</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:21.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78546K4</udiDi>
    <basicUdiDi>B-78546K4</basicUdiDi>
    <tradeName>GLUCOCARD 01 CONTROL</tradeName>
    <deviceName>GLUCOCARD 01 CONTROL</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78546</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:19.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-78482K3</udiDi>
    <basicUdiDi>B-78482K3</basicUdiDi>
    <tradeName>GLUCOCARD X-meter CONTROL</tradeName>
    <deviceName>GLUCOCARD X-meter CONTROL</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>78482</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:16.462Z</lastUpdated>
  </row>
</eudamedExport>