<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GM720UD</udiDi>
    <basicUdiDi>B-GM720UD</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM720</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>720G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM722UH</udiDi>
    <basicUdiDi>B-GM722UH</basicUdiDi>
    <tradeName>mylife Unio Neva 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>722G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM750UN</udiDi>
    <basicUdiDi>B-GM750UN</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>750G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM760UR</udiDi>
    <basicUdiDi>B-GM760UR</basicUdiDi>
    <tradeName>Rightest Blood Glucose Meter GM700 Pro</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>760G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM762UV</udiDi>
    <basicUdiDi>B-GM762UV</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM700 Pro 2</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>762G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM770UU</udiDi>
    <basicUdiDi>B-GM770UU</basicUdiDi>
    <tradeName>RIGHTEST Max 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>770G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM771UW</udiDi>
    <basicUdiDi>B-GM771UW</basicUdiDi>
    <tradeName>RIGHTEST Max Dual Blood Glucose and Ketone 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>771K01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM772UY</udiDi>
    <basicUdiDi>B-GM772UY</basicUdiDi>
    <tradeName>RIGHTEST Max 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>772G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM775V6</udiDi>
    <basicUdiDi>B-GM775V6</basicUdiDi>
    <tradeName>Mylife Unio Cara 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>775G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM780UX</udiDi>
    <basicUdiDi>B-GM780UX</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM700S</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>780G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GM782V3</udiDi>
    <basicUdiDi>B-GM782V3</basicUdiDi>
    <tradeName>RIGHTEST Blood Glucose Monitoring System GM700SB</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>782G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:20.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GP920VC</udiDi>
    <basicUdiDi>B-GP920VC</basicUdiDi>
    <tradeName>D-GP920VC</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>GP920</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:19.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GS100UK</udiDi>
    <basicUdiDi>B-GS100UK</basicUdiDi>
    <tradeName>Bionime Rightest GS100 Blood Glucose Test Strip</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>100G12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:19.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GS300UV</udiDi>
    <basicUdiDi>B-GS300UV</basicUdiDi>
    <tradeName>Bionime Rightest GS300 Blood Glucose Test Strip</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>300G12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:19.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GS770W6</udiDi>
    <basicUdiDi>B-GS770W6</basicUdiDi>
    <tradeName>Bionime Rightest Max Blood Glucose Test Strip</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>770G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:19.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NM700WL</udiDi>
    <basicUdiDi>B-NM700WL</basicUdiDi>
    <tradeName>RIGHTEST Sol 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>N700G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:57:59.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NM702WQ</udiDi>
    <basicUdiDi>B-NM702WQ</basicUdiDi>
    <tradeName>RIGHTEST Sol 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>N702G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:57:59.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NM710WP</udiDi>
    <basicUdiDi>B-NM710WP</basicUdiDi>
    <tradeName>RIGHTEST Brisa 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>N710G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:57:59.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NM712WT</udiDi>
    <basicUdiDi>B-NM712WT</basicUdiDi>
    <tradeName>RIGHTEST Brisa 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>N712G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:57:58.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NM720WS</udiDi>
    <basicUdiDi>B-NM720WS</basicUdiDi>
    <tradeName>RIGHTEST Alma 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>N720G01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:57:58.974Z</lastUpdated>
  </row>
</eudamedExport>