<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>D-109223MR</udiDi>
    <basicUdiDi>B-109223MR</basicUdiDi>
    <tradeName>OSMO STATION 2 (OM-6070)</tradeName>
    <deviceName>OSMO STATION 2 (OM-6070)</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>109223</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:45:29.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>03661540303425</udiDi>
    <basicUdiDi>B-03661540303425</basicUdiDi>
    <tradeName>Vapro Vapor Pressure Osmometer</tradeName>
    <deviceName>Vapro Vapor Pressure Osmometer</deviceName>
    <manufacturerName>ELITechGroup Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006942</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02079017</emdnCode>
    <emdnDescription>OSMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Model 5600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:16:53.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975488440744</udiDi>
    <basicUdiDi>697548844FPO22S3</basicUdiDi>
    <tradeName>Osmometer</tradeName>
    <deviceName>Osmometer</deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040107</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02079017</emdnCode>
    <emdnDescription>OSMOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPO-2000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:08:43.429Z</lastUpdated>
  </row>
</eudamedExport>