<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GM750UN</udiDi>
    <basicUdiDi>B-GM750UN</basicUdiDi>
    <tradeName>GE Blood Glucose Monitoring System GE200</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>750G01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:15.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM722UH</udiDi>
    <basicUdiDi>B-GM722UH</basicUdiDi>
    <tradeName>mylife Unio Neva Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>722G01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:14.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM720UD</udiDi>
    <basicUdiDi>B-GM720UD</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM720</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>720G01</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:14.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM700U7</udiDi>
    <basicUdiDi>B-GM700U7</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM700</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>700G01</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:13.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM572UN</udiDi>
    <basicUdiDi>B-GM572UN</basicUdiDi>
    <tradeName>RIGHTEST Wiz Plus Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>572G01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:09.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM570UJ</udiDi>
    <basicUdiDi>B-GM570UJ</basicUdiDi>
    <tradeName>RIGHTEST Wiz Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>570G01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:08.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM555UN</udiDi>
    <basicUdiDi>B-GM555UN</basicUdiDi>
    <tradeName>GE Blood Glucose Monitoring System GE100</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>555G01</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:07.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM551UE</udiDi>
    <basicUdiDi>B-GM551UE</basicUdiDi>
    <tradeName>RIGHTEST ALPHA Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>551G01</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:06.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM550UC</udiDi>
    <basicUdiDi>B-GM550UC</basicUdiDi>
    <tradeName>Rightest Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>550G01</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:37.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM300TK</udiDi>
    <basicUdiDi>B-GM300TK</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM300</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300G01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:36.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM282UA</udiDi>
    <basicUdiDi>B-GM282UA</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM280B</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>282G01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:35.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM280U6</udiDi>
    <basicUdiDi>B-GM280U6</basicUdiDi>
    <tradeName>GE Blood Glucose Monitoring System GE200</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>280G01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:33.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM260TY</udiDi>
    <basicUdiDi>B-GM260TY</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM260</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260G01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:31.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM236U3</udiDi>
    <basicUdiDi>B-GM236U3</basicUdiDi>
    <tradeName>RIGHTEST GT333 Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>236G01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:31.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM111TE</udiDi>
    <basicUdiDi>B-GM111TE</basicUdiDi>
    <tradeName>RIGHTEST ELSA Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111G01</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:29.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM110TC</udiDi>
    <basicUdiDi>B-GM110TC</basicUdiDi>
    <tradeName>RIGHTEST GM110 Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110G1</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:26.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM100T9</udiDi>
    <basicUdiDi>B-GM100T9</basicUdiDi>
    <tradeName>RIGHTEST GM100 Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100G01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:25.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G135-11UKS</udiDi>
    <basicUdiDi>B-G135-11UKS</basicUdiDi>
    <tradeName>On Call Sure Blood Glucose Test Strips</tradeName>
    <deviceName>On Call Sure Blood Glucose Test Strips</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G135-11U</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:17.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G135-11HJY</udiDi>
    <basicUdiDi>B-G135-11HJY</basicUdiDi>
    <tradeName>On Call Extra Blood Gucose Test Strips</tradeName>
    <deviceName>On Call Extra Blood Gucose Test Strips</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G135-11H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:13.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G135-10UKP</udiDi>
    <basicUdiDi>B-G135-10UKP</basicUdiDi>
    <tradeName>On Call Sure Blood Glucose Test Strips</tradeName>
    <deviceName>On Call Sure Blood Glucose Test Strips</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G135-10U</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:12.272Z</lastUpdated>
  </row>
</eudamedExport>