<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>B17384018010</udiDi>
    <basicUdiDi>++B1738401801NE</basicUdiDi>
    <tradeName>Sirius 2 Tube Luminometer</tradeName>
    <deviceName>Sirius 2 Tube Luminometer</deviceName>
    <manufacturerName>Spectral Medical Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000007450</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079099</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8401801</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:17:44.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771103954</udiDi>
    <basicUdiDi>B-08056771103954</basicUdiDi>
    <tradeName>LIAISON® ASYc</tradeName>
    <deviceName>LIAISON® ASYc</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02079082</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:40:09.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771103473</udiDi>
    <basicUdiDi>B-08056771103473</basicUdiDi>
    <tradeName>LIAISON® QuantiFERON® Software</tradeName>
    <deviceName>LIAISON® QuantiFERON® Software</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02079082</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:40:02.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>04061644052646</udiDi>
    <basicUdiDi>4061644PG0905DM</basicUdiDi>
    <tradeName>04061644052646</tradeName>
    <deviceName>Hand Brush, Brush Dispenser</deviceName>
    <manufacturerName>devemed GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W02079003</emdnCode>
    <emdnDescription>DISPENSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02-8700-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:00:43.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>03666628002580</udiDi>
    <basicUdiDi>366662880008GH</basicUdiDi>
    <tradeName>Distributeur de disques ATB - Rond 6 pastilles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTELLIGENCE ARTIFICIELLE APPLICATIONS</manufacturerName>
    <manufacturerSrn>FR-MF-000021688</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02079003</emdnCode>
    <emdnDescription>DISPENSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800226</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T15:28:38.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-70302GE</udiDi>
    <basicUdiDi>B-70302GE</basicUdiDi>
    <tradeName>Washing Solution (Concentration)</tradeName>
    <deviceName>Washing Solution (Concentration)</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>W02079085</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:07.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-60722GV</udiDi>
    <basicUdiDi>B-60722GV</basicUdiDi>
    <tradeName>OSMO STATION (OM-6060)</tradeName>
    <deviceName>OSMO STATION (OM-6060)</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>W02079017</emdnCode>
    <emdnDescription>OSMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60722</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:16:22.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-60704GT</udiDi>
    <basicUdiDi>B-60704GT</basicUdiDi>
    <tradeName>OSMO STATION (OM-6060)</tradeName>
    <deviceName>OSMO STATION (OM-6060)</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>W02079017</emdnCode>
    <emdnDescription>OSMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60704</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:16:21.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-60703GR</udiDi>
    <basicUdiDi>B-60703GR</basicUdiDi>
    <tradeName>OSMO STATION (OM-6060)</tradeName>
    <deviceName>OSMO STATION (OM-6060)</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>W02079017</emdnCode>
    <emdnDescription>OSMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60703</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:16:17.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-60505GK</udiDi>
    <basicUdiDi>B-60505GK</basicUdiDi>
    <tradeName>OSMO STATION (OM-6050)</tradeName>
    <deviceName>OSMO STATION (OM-6050)</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>W02079017</emdnCode>
    <emdnDescription>OSMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60505</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:16:15.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-60504GH</udiDi>
    <basicUdiDi>B-60504GH</basicUdiDi>
    <tradeName>OSMO STATION (OM-6050)</tradeName>
    <deviceName>OSMO STATION (OM-6050)</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>W02079017</emdnCode>
    <emdnDescription>OSMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60504</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:16:09.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-60503GF</udiDi>
    <basicUdiDi>B-60503GF</basicUdiDi>
    <tradeName>OSMO STATION (OM-6050)</tradeName>
    <deviceName>OSMO STATION (OM-6050)</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>W02079017</emdnCode>
    <emdnDescription>OSMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60503</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:16:08.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133010013</udiDi>
    <basicUdiDi>880613301001BC</basicUdiDi>
    <tradeName>i-Chamber</tradeName>
    <deviceName>i-Chamber</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079008</emdnCode>
    <emdnDescription>HEATING MANTLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPRR009</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:43:05.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440261148</udiDi>
    <basicUdiDi>84354402MDX_VSMARTOFF5E</basicUdiDi>
    <tradeName>VIASURE V-Smart Offline</tradeName>
    <deviceName>VIASURE V-Smart Offline</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079092</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPCR-SW06-CL</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:54.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>80528594700008</udiDi>
    <basicUdiDi>805285947SWDMSPZ</basicUdiDi>
    <tradeName>80528594700008</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DASIT SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000050554</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079092</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM11DMS01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:04:31.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052478984377</udiDi>
    <basicUdiDi>805247898BUCKETM8</basicUdiDi>
    <tradeName>UltraSAFE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MILESTONE S.P.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000024414</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079099</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:57:00.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052478980133</udiDi>
    <basicUdiDi>805247898VACUUMBAG4X</basicUdiDi>
    <tradeName>SEALSAFE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MILESTONE S.P.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000024414</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079099</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>68461</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:56:55.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>04995047072485</udiDi>
    <basicUdiDi>4995047PathologyVDUKU</basicUdiDi>
    <tradeName>PX3150-BK</tradeName>
    <deviceName>Pathology Monitor</deviceName>
    <manufacturerName>EIZO Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016570</manufacturerSrn>
    <authorisedRepresentativeName>EIZO GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000014107</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079080</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PX3150JABK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:41:10.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289513746</udiDi>
    <basicUdiDi>42502895HERALH</basicUdiDi>
    <tradeName>HERA</tradeName>
    <deviceName>HERA</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079092</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HER-1000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:52:51.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>04061644018963</udiDi>
    <basicUdiDi>4061644PG0905DM</basicUdiDi>
    <tradeName>04061644018963</tradeName>
    <deviceName>Hand Brush, Brush Dispenser</deviceName>
    <manufacturerName>devemed GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W02079003</emdnCode>
    <emdnDescription>DISPENSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8700-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:40:58.270Z</lastUpdated>
  </row>
</eudamedExport>