<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>89061707102180</udiDi>
    <basicUdiDi>890617071AVMEDCHZ</basicUdiDi>
    <tradeName>MAXLYTE</tradeName>
    <deviceName>Maxlyte Daily Cleaning Solution</deviceName>
    <manufacturerName>Avecon Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000040691</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVMEDC-90</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:37.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>89061707102012</udiDi>
    <basicUdiDi>890617071AVHTSHE</basicUdiDi>
    <tradeName>MAXCOUNT</tradeName>
    <deviceName>Maxcount Sheath fluid</deviceName>
    <manufacturerName>Avecon Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000040691</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVHTS560-10</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:36.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>89061707101954</udiDi>
    <basicUdiDi>890617071AVHTESLC</basicUdiDi>
    <tradeName>MAXCOUNT</tradeName>
    <deviceName>Maxcount Detergent</deviceName>
    <manufacturerName>Avecon Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000040691</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVHTE560-20</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:32.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>89061707101886</udiDi>
    <basicUdiDi>890617071AVHTPH8</basicUdiDi>
    <tradeName>Maxcount</tradeName>
    <deviceName>Maxcount Probe cleaner</deviceName>
    <manufacturerName>Avecon Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000040691</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVHTP - 50</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:31.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>89061707101718</udiDi>
    <basicUdiDi>890617071AVHTLGY</basicUdiDi>
    <tradeName>MAXCOUNT</tradeName>
    <deviceName>Maxcount Lyse reagent</deviceName>
    <manufacturerName>Avecon Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000040691</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVHTL60P - 500, AVHTL70P - 500, AVHTL560 - 500</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:30.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>89061707101640</udiDi>
    <basicUdiDi>890617071AVHTDGG</basicUdiDi>
    <tradeName>MAXCOUNT</tradeName>
    <deviceName>MaxCount Diluent Reagent</deviceName>
    <manufacturerName>Avecon Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000040691</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVHTD60P - 20, AVHTD70P - 20, AVHTD560 - 20</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:30.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>18906074561968</udiDi>
    <basicUdiDi>8905459MERILEIAWASH8N</basicUdiDi>
    <tradeName>18906074561968</tradeName>
    <deviceName>Merilyzer EIAWash</deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAAEIW-03</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:38:44.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>18906074560756</udiDi>
    <basicUdiDi>8905459RINSEHMG6</basicUdiDi>
    <tradeName>18906074560756</tradeName>
    <deviceName>CelQuant 3i Rinse</deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLZCCR-04</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:38:42.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>86818125250916</udiDi>
    <basicUdiDi>869901528HD00KY</basicUdiDi>
    <tradeName>DS DILUENT [EN]</tradeName>
    <deviceName>Haematology Reagents</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5950MN</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:00:48.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>86818125005868</udiDi>
    <basicUdiDi>869901528AR00LM</basicUdiDi>
    <tradeName>PROBE CLEANSER [EN]</tradeName>
    <deviceName>Auxiliary Reagent</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8050MN</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:00:47.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156385893</udiDi>
    <basicUdiDi>8592156H7REC301U4</basicUdiDi>
    <tradeName>Erba H7100 Clean 10x4 mL</tradeName>
    <deviceName>Erba H7100 Clean</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00063</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:26:07.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156385879</udiDi>
    <basicUdiDi>8592156H7RFD301UN</basicUdiDi>
    <tradeName>Erba H7100 Fluro Diff (22 mL)</tradeName>
    <deviceName>Erba H7100 Fluro Diff</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00053</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:26:06.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156385855</udiDi>
    <basicUdiDi>8592156H7RFR301XQ</basicUdiDi>
    <tradeName>Erba H7100 Fluro Ret (12 mL)</tradeName>
    <deviceName>Erba H7100 Fluro Ret</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00051</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:26:02.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156385794</udiDi>
    <basicUdiDi>8592156H7REL301W3</basicUdiDi>
    <tradeName>Erba H7100 Lyse 1 (500 mL)</tradeName>
    <deviceName>Erba H7100 Lyse</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00046</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:26:02.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156385787</udiDi>
    <basicUdiDi>8592156H7RED301UB</basicUdiDi>
    <tradeName>Erba H7100 Dil Ret (1 L)</tradeName>
    <deviceName>Erba H7100 Dil Ret</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00065</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:26:01.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156385770</udiDi>
    <basicUdiDi>8592156H7DIL301RR</basicUdiDi>
    <tradeName>Erba H7100 Dil</tradeName>
    <deviceName>Erba H7100 Dil</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00044</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:26:00.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156148184</udiDi>
    <basicUdiDi>8592156HERE0306XD</basicUdiDi>
    <tradeName>Erba H560 Lyse1</tradeName>
    <deviceName>Erba H560 Lyse</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00031</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:54.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156148177</udiDi>
    <basicUdiDi>8592156HEDIL306YY</basicUdiDi>
    <tradeName>Erba H560 Dil</tradeName>
    <deviceName>Erba H560 Dil</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00030</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:50.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156148160</udiDi>
    <basicUdiDi>8592156HERE0308XH</basicUdiDi>
    <tradeName>Erba H360 Lyse</tradeName>
    <deviceName>Erba H360 Lyse</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00029</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:49.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156148153</udiDi>
    <basicUdiDi>8592156HEDIL308Z4</basicUdiDi>
    <tradeName>Erba H360 Dil</tradeName>
    <deviceName>Erba H360 Dil</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00028</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:48.435Z</lastUpdated>
  </row>
</eudamedExport>