<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-CNMF000014455GUK-S021L9</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-S021L9</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-S021L9</tradeName>
    <deviceName>Uric Acid Test Strips</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S021</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:13:25.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-OTH-A4604K</udiDi>
    <basicUdiDi>B-ABT-OTH-A4604K</basicUdiDi>
    <tradeName>Accu-Tell® Total Hardness Test</tradeName>
    <deviceName>Accu-Tell® Total Hardness Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-OTH-A460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:32.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>80575028800131</udiDi>
    <basicUdiDi>B-80575028800131</basicUdiDi>
    <tradeName>80575028800131</tradeName>
    <deviceName>CLINI CHOL 10 TEST</deviceName>
    <manufacturerName>Callegari S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000035568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD19124P</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:42:04.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-720000N8</udiDi>
    <basicUdiDi>B-720000N8</basicUdiDi>
    <tradeName>ZuhauseTEST PSA</tradeName>
    <deviceName>ZuhauseTEST PSA</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>720000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T05:59:49.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350123504606</udiDi>
    <basicUdiDi>B-07350123504606</basicUdiDi>
    <tradeName>Vaginal pH Rapid Test Panel</tradeName>
    <deviceName>Vaginal pH Rapid Test Panel</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVPH-504H</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:29.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090082590059</udiDi>
    <basicUdiDi>B-07090082590059</basicUdiDi>
    <tradeName>Lyfstone Calprotectin for Synovial Fluid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Calpro AS</manufacturerName>
    <manufacturerSrn>NO-MF-000036194</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYFCLP005</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:57:31.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090028590051</udiDi>
    <basicUdiDi>B-07090028590051</basicUdiDi>
    <tradeName>07090028590051</tradeName>
    <deviceName>Lyfstone Calprotectin for synovial fluid</deviceName>
    <manufacturerName>Calpro AS</manufacturerName>
    <manufacturerSrn>NO-MF-000036194</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYFCLP005</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:57:16.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090028590013</udiDi>
    <basicUdiDi>B-07090028590013</basicUdiDi>
    <tradeName>Lyfstone Calprotectin for Synovial Fluid</tradeName>
    <deviceName>Lyfstone Calprotectin (CLP) Quantitative Test</deviceName>
    <manufacturerName>Calpro AS</manufacturerName>
    <manufacturerSrn>NO-MF-000036194</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYFCLP001</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:57:15.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978198484015</udiDi>
    <basicUdiDi>B-06978198484015</basicUdiDi>
    <tradeName>Vaginal Secretions Analysis Strip</tradeName>
    <deviceName>Vaginal Secretions Analysis Strip</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:30.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974246461182</udiDi>
    <basicUdiDi>B-06974246461182</basicUdiDi>
    <tradeName>Safecare THC Rapid Test Panel (Saliva)</tradeName>
    <deviceName>Marijuana(THC) Rapid Test (Saliva)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THC-7014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:38:19.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046681003622</udiDi>
    <basicUdiDi>4046681152337WS</basicUdiDi>
    <tradeName>pH-Fix 4.5 - 10.0 PT</tradeName>
    <deviceName>pH-Fix 4.5 - 10.0 PT</deviceName>
    <manufacturerName>MACHEREY-NAGEL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:16:37.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804823160</udiDi>
    <basicUdiDi>B-06952804823160</basicUdiDi>
    <tradeName>06952804823160</tradeName>
    <deviceName>Vaginal pH Test Device</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PH-S23H</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:00.192Z</lastUpdated>
  </row>
</eudamedExport>