<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-G115-10HJ3</udiDi>
    <basicUdiDi>B-G115-10HJ3</basicUdiDi>
    <tradeName>On Call Extra Blood Glucose Monitoring System</tradeName>
    <deviceName>On Call Extra Blood Glucose Monitoring System</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>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G115-10H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:42:13.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIHBA-402aSW</udiDi>
    <basicUdiDi>B-FIHBA-402aSW</basicUdiDi>
    <tradeName>HbA1c Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>HbA1c Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIHBA-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:28:52.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIHBA-402aHGPC</udiDi>
    <basicUdiDi>B-FIHBA-402aHGPC</basicUdiDi>
    <tradeName>HbA1c Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>HbA1c Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIHBA-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:28:48.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-HBA-402HX</udiDi>
    <basicUdiDi>B-FI-HBA-402HX</basicUdiDi>
    <tradeName>D-FI-HBA-402HX</tradeName>
    <deviceName>HbA1c Test Cassette</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-HBA-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:47.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT007077</udiDi>
    <basicUdiDi>B-DT007077</basicUdiDi>
    <tradeName>Unicorn-HbA1c</tradeName>
    <deviceName>Unicorn-HbA1c</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0070</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:15:20.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT00066W</udiDi>
    <basicUdiDi>B-DT00066W</basicUdiDi>
    <tradeName>Unicorn-HbA1c</tradeName>
    <deviceName>Unicorn-HbA1c</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:14:12.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GLU-S4197</udiDi>
    <basicUdiDi>B-CNMF000014455-GLU-S4197</basicUdiDi>
    <tradeName>D-CNMF000014455-GLU-S4197</tradeName>
    <deviceName>Blood Glucose 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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-S41</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:58.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GCA-S31WG</udiDi>
    <basicUdiDi>B-CNMF000014455-GCA-S31WG</basicUdiDi>
    <tradeName>D-CNMF000014455-GCA-S31WG</tradeName>
    <deviceName>GluCoA1c Glycohemoglobin Test Kit</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCA-S31</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:20.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GCA-S33WL</udiDi>
    <basicUdiDi>B-CNMF000014455-GCA-S33WL</basicUdiDi>
    <tradeName>D-CNMF000014455-GCA-S33WL</tradeName>
    <deviceName>GluCoA1c Glycohemoglobin Test Kit</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCA-S33</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:20.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GCA-S23WH</udiDi>
    <basicUdiDi>B-CNMF000014455-GCA-S23WH</basicUdiDi>
    <tradeName>D-CNMF000014455-GCA-S23WH</tradeName>
    <deviceName>GluCoA1c Glycohemoglobin Test Kit</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCA-S23</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:14.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-GCA-S21WD</udiDi>
    <basicUdiDi>B-CNMF000014455-GCA-S21WD</basicUdiDi>
    <tradeName>D-CNMF000014455-GCA-S21WD</tradeName>
    <deviceName>GluCoA1c Glycohemoglobin Test Kit</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCA-S21</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:12:13.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CMLMLS-101GD</udiDi>
    <basicUdiDi>B-CMLMLS-101GD</basicUdiDi>
    <tradeName>D-CMLMLS-101GD</tradeName>
    <deviceName>Cholesterol Test Device and Cholesterol Meter</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060102</emdnCode>
    <emdnDescription>CHOLESTEROL TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Meter: CML-101 Device: MLS-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:08:52.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C131-6017T4</udiDi>
    <basicUdiDi>B-C131-6017T4</basicUdiDi>
    <tradeName>QUIK-CHECK Ultra Hemoglobin Test Strips</tradeName>
    <deviceName>QUIK-CHECK Ultra Hemoglobin 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 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>C131-6017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:04.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C131-6011SQ</udiDi>
    <basicUdiDi>B-C131-6011SQ</basicUdiDi>
    <tradeName>Mission Ultra Hemoglobin Test Strips</tradeName>
    <deviceName>Mission Ultra Hemoglobin 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 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>C131-6011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:03.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C131-5017SV</udiDi>
    <basicUdiDi>B-C131-5017SV</basicUdiDi>
    <tradeName>QUIK-CHECK Ultra Total Cholesterol Test Strips</tradeName>
    <deviceName>QUIK-CHECK Ultra Total Cholesterol 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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060102</emdnCode>
    <emdnDescription>CHOLESTEROL TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C131-5017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:02.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C131-2047SH</udiDi>
    <basicUdiDi>B-C131-2047SH</basicUdiDi>
    <tradeName>QUIK-CHECK Cholesterol Test Device 3-in-1 Lipid Panel</tradeName>
    <deviceName>QUIK-CHECK Cholesterol Test Device 3-in-1 Lipid Panel</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 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>C131-2047</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:52:58.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C131-2041S5</udiDi>
    <basicUdiDi>B-C131-2041S5</basicUdiDi>
    <tradeName>Mission Cholesterol Test Device 3-in-1 Lipid Panel</tradeName>
    <deviceName>Mission Cholesterol Test Device 3-in-1 Lipid Panel</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 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>C131-2041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:52:57.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C131-5011SH</udiDi>
    <basicUdiDi>B-C131-5011SH</basicUdiDi>
    <tradeName>Mission Ultra Total Cholesterol Test Strips</tradeName>
    <deviceName>Mission Ultra Total Cholesterol 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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060102</emdnCode>
    <emdnDescription>CHOLESTEROL TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C131-5011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:52:57.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C131-2051S8</udiDi>
    <basicUdiDi>B-C131-2051S8</basicUdiDi>
    <tradeName>Mission Cholesterol Test Device 3-in-1 Lipid Panel</tradeName>
    <deviceName>Mission Cholesterol Test Device 3-in-1 Lipid Panel</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 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>C131-2051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:52:56.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C131-2037SE</udiDi>
    <basicUdiDi>B-C131-2037SE</basicUdiDi>
    <tradeName>QUIK-CHECK HDL High Density Lipoprotein Test Devices</tradeName>
    <deviceName>QUIK-CHECK HDL High Density Lipoprotein Test Devices</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060103</emdnCode>
    <emdnDescription>HDL TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C131-2037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:52:39.346Z</lastUpdated>
  </row>
</eudamedExport>