<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975429090229</udiDi>
    <basicUdiDi>B-06975429090229</basicUdiDi>
    <tradeName>General Chemistry III Kit (Microfluidic Dry Chemistry)</tradeName>
    <deviceName>General Chemistry III Kit (Microfluidic Dry Chemistry)</deviceName>
    <manufacturerName>Chengdu Polytech Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034373</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD10387</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T07:18:49.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547410384642</udiDi>
    <basicUdiDi>B-04547410384642</basicUdiDi>
    <tradeName>FUJI DRI-CHEM SLIDE Small Screening S-Panel</tradeName>
    <deviceName>FUJI DRI-CHEM SLIDE Small Screening S-Panel</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410384642</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:10:32.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547410311594</udiDi>
    <basicUdiDi>B-04547410311594</basicUdiDi>
    <tradeName>FUJI DRI-CHEM SLIDE Comprehensive S-Panel</tradeName>
    <deviceName>FUJI DRI-CHEM SLIDE Comprehensive S-Panel</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410311594</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-25T09:10:31.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979845480107</udiDi>
    <basicUdiDi>B-06979845480107</basicUdiDi>
    <tradeName>06979845480107</tradeName>
    <deviceName>Reagent Kit for Automatic Biochemistry Analyzer</deviceName>
    <manufacturerName>Hunan Runmei Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017635</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RM-R03-014-1.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:38:56.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979845480091</udiDi>
    <basicUdiDi>B-06979845480091</basicUdiDi>
    <tradeName>06979845480091</tradeName>
    <deviceName>Reagent Kit for Automatic Biochemistry Analyzer</deviceName>
    <manufacturerName>Hunan Runmei Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017635</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RM-R03-014-1.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:38:54.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979845480084</udiDi>
    <basicUdiDi>B-06979845480084</basicUdiDi>
    <tradeName>06979845480084</tradeName>
    <deviceName>Reagent Kit for Automatic Biochemistry Analyzer</deviceName>
    <manufacturerName>Hunan Runmei Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017635</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RM-R03-014-1.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:38:53.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979845480077</udiDi>
    <basicUdiDi>B-06979845480077</basicUdiDi>
    <tradeName>06979845480077</tradeName>
    <deviceName>Reagent Kit for Automatic Biochemistry Analyzer</deviceName>
    <manufacturerName>Hunan Runmei Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017635</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RM-R03-014-1.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:38:52.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979845480060</udiDi>
    <basicUdiDi>B-06979845480060</basicUdiDi>
    <tradeName>06979845480060</tradeName>
    <deviceName>Reagent Kit for Automatic Biochemistry Analyzer</deviceName>
    <manufacturerName>Hunan Runmei Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017635</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RM-R03-014-1.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:38:52.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979845480053</udiDi>
    <basicUdiDi>B-06979845480053</basicUdiDi>
    <tradeName>06979845480053</tradeName>
    <deviceName>Reagent Kit for Automatic Biochemistry Analyzer</deviceName>
    <manufacturerName>Hunan Runmei Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017635</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RM-R03-014-1.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:38:48.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979845480046</udiDi>
    <basicUdiDi>B-06979845480046</basicUdiDi>
    <tradeName>06979845480046</tradeName>
    <deviceName>Reagent Kit for Automatic Biochemistry Analyzer</deviceName>
    <manufacturerName>Hunan Runmei Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017635</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RM-R03-014-1.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:38:47.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979845480039</udiDi>
    <basicUdiDi>B-06979845480039</basicUdiDi>
    <tradeName>06979845480039</tradeName>
    <deviceName>Reagent Kit for Automatic Biochemistry Analyzer</deviceName>
    <manufacturerName>Hunan Runmei Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017635</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RM-R03-014-1.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:38:46.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996097338</udiDi>
    <basicUdiDi>B-06950996097338</basicUdiDi>
    <tradeName>URcheck Liver Function Lyophilized Kit 12</tradeName>
    <deviceName>URcheck Liver Function Lyophilized Kit 12</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>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LF-002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:49.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996060400</udiDi>
    <basicUdiDi>B-06950996060400</basicUdiDi>
    <tradeName>URcheck Health Check Lyophilized Kit 19</tradeName>
    <deviceName>URcheck Health Check Lyophilized Kit 19</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>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYN-004</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:44.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996045995</udiDi>
    <basicUdiDi>B-06950996045995</basicUdiDi>
    <tradeName>URcheck Renal Function Lyophilized Kit 9</tradeName>
    <deviceName>URcheck Renal Function Lyophilized Kit 9</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>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:43.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996033657</udiDi>
    <basicUdiDi>B-06950996033657</basicUdiDi>
    <tradeName>URcheck Clinical Emergency Lyophilized Kit 12</tradeName>
    <deviceName>URcheck Clinical Emergency Lyophilized Kit 12</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>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:42.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996022750</udiDi>
    <basicUdiDi>B-06950996022750</basicUdiDi>
    <tradeName>URcheck Cardiovascular Risk Marker Lyophilized Kit 5</tradeName>
    <deviceName>URcheck Cardiovascular Risk Marker Lyophilized Kit 5</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>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:41.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996011686</udiDi>
    <basicUdiDi>B-06950996011686</basicUdiDi>
    <tradeName>URcheck Electrolytes Lyophilized Kit 9</tradeName>
    <deviceName>URcheck Electrolytes Lyophilized Kit 9</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>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELE-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:37.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A018D2</udiDi>
    <basicUdiDi>B-A018D2</basicUdiDi>
    <tradeName>INDICAID™ Multiple Urine Test Strip</tradeName>
    <deviceName>INDICAID™ Multiple Urine Test Strip</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Multiple Urine Test Strip</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:24.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77961KD</udiDi>
    <basicUdiDi>B-77961KD</basicUdiDi>
    <tradeName>SPOTCHEM D Total-B</tradeName>
    <deviceName>SPOTCHEM D Total-B</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77961</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:15.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77957KN</udiDi>
    <basicUdiDi>B-77957KN</basicUdiDi>
    <tradeName>SPOTCHEM D Liver</tradeName>
    <deviceName>SPOTCHEM D Liver</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77957</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:14.759Z</lastUpdated>
  </row>
</eudamedExport>