<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04710949332693</udiDi>
    <basicUdiDi>471094933GD00001VG</basicUdiDi>
    <tradeName>mylife Softlance GD500 Lancing Devices</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>700023999</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:26.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710949333034</udiDi>
    <basicUdiDi>471094933GD00002VJ</basicUdiDi>
    <tradeName>mylife AutoLance GD720 Lancing Devices</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>700023995</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:26.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710949333157</udiDi>
    <basicUdiDi>471094933GD00001VG</basicUdiDi>
    <tradeName>RIGHTEST GD500 Lancing Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0B000</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:26.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GC300RD</udiDi>
    <basicUdiDi>B-GC300RD</basicUdiDi>
    <tradeName>Bionime Rightest GC300 Glucose Control Solution</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300G16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:51.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GD500RW</udiDi>
    <basicUdiDi>B-GD500RW</basicUdiDi>
    <tradeName>D-GD500RW</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500D01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:33.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GD720SE</udiDi>
    <basicUdiDi>B-GD720SE</basicUdiDi>
    <tradeName>D-GD720SE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>720D01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:33.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM100T9</udiDi>
    <basicUdiDi>B-GM100T9</basicUdiDi>
    <tradeName>RIGHTEST GM100 Blood Glucose Monitoring System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM110TC</udiDi>
    <basicUdiDi>B-GM110TC</basicUdiDi>
    <tradeName>RIGHTEST GM110 Blood Glucose Monitoring System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110G1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM111TE</udiDi>
    <basicUdiDi>B-GM111TE</basicUdiDi>
    <tradeName>RIGHTEST ELSA Blood Glucose Monitoring System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM236U3</udiDi>
    <basicUdiDi>B-GM236U3</basicUdiDi>
    <tradeName>RIGHTEST GT333 Blood Glucose Monitoring System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>236G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM260TY</udiDi>
    <basicUdiDi>B-GM260TY</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM260</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM280U6</udiDi>
    <basicUdiDi>B-GM280U6</basicUdiDi>
    <tradeName>GE Blood Glucose Monitoring System GE200</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>280G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM282UA</udiDi>
    <basicUdiDi>B-GM282UA</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM280B</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>282G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM300TK</udiDi>
    <basicUdiDi>B-GM300TK</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM300</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM550UC</udiDi>
    <basicUdiDi>B-GM550UC</basicUdiDi>
    <tradeName>Rightest Blood Glucose Monitoring System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>550G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM551UE</udiDi>
    <basicUdiDi>B-GM551UE</basicUdiDi>
    <tradeName>RIGHTEST ALPHA Blood Glucose Monitoring System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>551G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM555UN</udiDi>
    <basicUdiDi>B-GM555UN</basicUdiDi>
    <tradeName>GE Blood Glucose Monitoring System GE100</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>555G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM570UJ</udiDi>
    <basicUdiDi>B-GM570UJ</basicUdiDi>
    <tradeName>RIGHTEST Wiz Blood Glucose Monitoring System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>570G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM572UN</udiDi>
    <basicUdiDi>B-GM572UN</basicUdiDi>
    <tradeName>RIGHTEST Wiz Plus Blood Glucose Monitoring System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>572G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM700U7</udiDi>
    <basicUdiDi>B-GM700U7</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM700</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>700G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.330Z</lastUpdated>
  </row>
</eudamedExport>