<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-69750225320175CEL5S6</udiDi>
    <basicUdiDi>B-69750225320175CEL5S6</basicUdiDi>
    <tradeName>D-69750225320175CEL5S6</tradeName>
    <deviceName>Creatinine Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060112</emdnCode>
    <emdnDescription>CREATININE ANALYSIS TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iCR 10,iCR 11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:09.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225320174CEKYTW</udiDi>
    <basicUdiDi>B-69750225320174CEKYTW</basicUdiDi>
    <tradeName>D-69750225320174CEKYTW</tradeName>
    <deviceName>Blood Uric Acid Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN400R1、EN400R2、 EN400R3、EN400R4、</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:08.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225320171CEKHRT</udiDi>
    <basicUdiDi>B-69750225320171CEKHRT</basicUdiDi>
    <tradeName>D-69750225320171CEKHRT</tradeName>
    <deviceName>Blood Lactate Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN300R1、EN300R2、EN300R3、EN300R4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:02.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225319171CENMX2</udiDi>
    <basicUdiDi>B-69750225319171CENMX2</basicUdiDi>
    <tradeName>D-69750225319171CENMX2</tradeName>
    <deviceName>Blood Glucose Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN200R1、EN200R2、EN200R3、EN200R4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:01.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225319172CENSXR</udiDi>
    <basicUdiDi>B-69750225319172CENSXR</basicUdiDi>
    <tradeName>D-69750225319172CENSXR</tradeName>
    <deviceName>Blood β-Ketone Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN500R1、EN500R2、 EN500R3、 EN500R4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:00.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697191378-UATSHP</udiDi>
    <basicUdiDi>B-697191378-UATSHP</basicUdiDi>
    <tradeName>ACCU-ANSWER</tradeName>
    <deviceName>Uric Acid Test Strips</deviceName>
    <manufacturerName>Guilin Royalyze Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038422</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:12.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697191378-TCTSHS</udiDi>
    <basicUdiDi>B-697191378-TCTSHS</basicUdiDi>
    <tradeName>ACCU-ANSWER</tradeName>
    <deviceName>Total Cholesterol Test Strips</deviceName>
    <manufacturerName>Guilin Royalyze Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038422</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060102</emdnCode>
    <emdnDescription>CHOLESTEROL TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:10.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697191378-HTSKG</udiDi>
    <basicUdiDi>B-697191378-HTSKG</basicUdiDi>
    <tradeName>ACCU-ANSWER</tradeName>
    <deviceName>Hemoglobin Test Strips</deviceName>
    <manufacturerName>Guilin Royalyze Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038422</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:05.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697191378-BGTSEG</udiDi>
    <basicUdiDi>B-697191378-BGTSEG</basicUdiDi>
    <tradeName>ACCU-ANSWER</tradeName>
    <deviceName>Blood Glucose Test Strips</deviceName>
    <manufacturerName>Guilin Royalyze Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038422</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:05.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712027479R</udiDi>
    <basicUdiDi>B-69717712027479R</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Blood Glucose Test Strip</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EGS-101(2x25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:00:42.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712021748W</udiDi>
    <basicUdiDi>B-69717712021748W</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUS-101(2x25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:59:22.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712021508G</udiDi>
    <basicUdiDi>B-69717712021508G</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUS-101(50PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:59:22.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712021438K</udiDi>
    <basicUdiDi>B-69717712021438K</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EUS-101(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:59:22.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712020688W</udiDi>
    <basicUdiDi>B-69717712020688W</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Blood Glucose Test Strip</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EGS-101(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:59:21.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712020518D</udiDi>
    <basicUdiDi>B-69717712020518D</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Blood Glucose Test Strip</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EGS-101(50PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:59:14.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712018499T</udiDi>
    <basicUdiDi>B-69717712018499T</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>High Density Lipoprotein Cholesterol Test Strip (Dry Chemistry)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060103</emdnCode>
    <emdnDescription>HDL TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLS-101(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:59:10.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697177120174094</udiDi>
    <basicUdiDi>B-697177120174094</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Triglycerides Test Strip (Dry Chemistry)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060105</emdnCode>
    <emdnDescription>TRIGLYCERIDE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TGS-101(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:59:06.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712016418Z</udiDi>
    <basicUdiDi>B-69717712016418Z</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Total Cholesterol Test Strip(Dry Chemistry)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060102</emdnCode>
    <emdnDescription>CHOLESTEROL TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCS-101（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:58.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712015428W</udiDi>
    <basicUdiDi>B-69717712015428W</basicUdiDi>
    <tradeName>D-69717712015428W</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3020701001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:49.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712014438T</udiDi>
    <basicUdiDi>B-69717712014438T</basicUdiDi>
    <tradeName>D-69717712014438T</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060112</emdnCode>
    <emdnDescription>CREATININE ANALYSIS TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3020500401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:32.630Z</lastUpdated>
  </row>
</eudamedExport>