<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-MC-780MA-N_WH_SepaKB</udiDi>
    <basicUdiDi>B-MC-780MA-N_WH_SepaKB</basicUdiDi>
    <tradeName>Body Composition Analyzer</tradeName>
    <deviceName>Body Composition Analyzer</deviceName>
    <manufacturerName>TANITA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022755</manufacturerSrn>
    <authorisedRepresentativeName>TANITA Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000003401</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099001</emdnCode>
    <emdnDescription>BODY IMPEDANCE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC-780MA-N_WH_Sepa</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:53:46.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MC-780MA-N_DG_Sepa8T</udiDi>
    <basicUdiDi>B-MC-780MA-N_DG_Sepa8T</basicUdiDi>
    <tradeName>Body Composition Analyzer</tradeName>
    <deviceName>Body Composition Analyzer</deviceName>
    <manufacturerName>TANITA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022755</manufacturerSrn>
    <authorisedRepresentativeName>TANITA Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000003401</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099001</emdnCode>
    <emdnDescription>BODY IMPEDANCE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC-780MA-N_DG_Sepa</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:53:46.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC-430MASP</udiDi>
    <basicUdiDi>B-DC-430MASP</basicUdiDi>
    <tradeName>Body Composition Analyzer</tradeName>
    <deviceName>Body Composition Analyzer</deviceName>
    <manufacturerName>TANITA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022755</manufacturerSrn>
    <authorisedRepresentativeName>TANITA Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000003401</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099001</emdnCode>
    <emdnDescription>BODY IMPEDANCE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC-430MA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:17.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC-240MA_NVXW</udiDi>
    <basicUdiDi>B-DC-240MA_NVXW</basicUdiDi>
    <tradeName>Body composition analyzer</tradeName>
    <deviceName>Body Composition Analyzer</deviceName>
    <manufacturerName>TANITA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000022755</manufacturerSrn>
    <authorisedRepresentativeName>TANITA Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000003401</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099001</emdnCode>
    <emdnDescription>BODY IMPEDANCE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC-240MA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:16.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B2772726995SR</udiDi>
    <basicUdiDi>B-D-B2772726995SR</basicUdiDi>
    <tradeName>D-B2772726995SR</tradeName>
    <deviceName>SOZO Digital Health Platform</deviceName>
    <manufacturerName>ImpediMed Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000041154</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099001</emdnCode>
    <emdnDescription>BODY IMPEDANCE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2726995</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:12:02.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BE-MF-000043005CA</udiDi>
    <basicUdiDi>B-BE-MF-000043005CA</basicUdiDi>
    <tradeName>D-BE-MF-000043005CA</tradeName>
    <deviceName>NephroFlow UFV Module</deviceName>
    <manufacturerName>Nipro Digital Technologies Europe NV</manufacturerName>
    <manufacturerSrn>BE-MF-000043005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099092</emdnCode>
    <emdnDescription>VARIOUS NEPHROLOGY AND HAEMODIALYSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V1.0.2</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:23:30.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>B2772726995SR</udiDi>
    <basicUdiDi>B-B2772726995SR</basicUdiDi>
    <tradeName>SOZO</tradeName>
    <deviceName>SOZO Digital Health Platform</deviceName>
    <manufacturerName>ImpediMed Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000041154</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099001</emdnCode>
    <emdnDescription>BODY IMPEDANCE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2726695</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:42:23.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7290015331005V2</udiDi>
    <basicUdiDi>B-7290015331005V2</basicUdiDi>
    <tradeName>D-7290015331005V2</tradeName>
    <deviceName>NICaS CS</deviceName>
    <manufacturerName>New NI Medical (2011) Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000015363</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099001</emdnCode>
    <emdnDescription>BODY IMPEDANCE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7290015331005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:05:32.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>42607708200242</udiDi>
    <basicUdiDi>B-42607708200242</basicUdiDi>
    <tradeName>42607708200242</tradeName>
    <deviceName>ECOMix Revolution</deviceName>
    <manufacturerName>Intermedt Medizin &amp; Technik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006369</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099006</emdnCode>
    <emdnDescription>LIQUID DIALYSIS PREPARATIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3284</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:09:56.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>42607708200174</udiDi>
    <basicUdiDi>B-42607708200174</basicUdiDi>
    <tradeName>42607708200174</tradeName>
    <deviceName>ECOMix</deviceName>
    <manufacturerName>Intermedt Medizin &amp; Technik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006369</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099006</emdnCode>
    <emdnDescription>LIQUID DIALYSIS PREPARATIONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2777</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:09:55.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251815200277</udiDi>
    <basicUdiDi>42518152HY001AT</basicUdiDi>
    <tradeName>HP5500D 500 P/H</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HERCO Wassertechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007521</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12099007</emdnCode>
    <emdnDescription>DIALYSIS WATER TREATMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00465902</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T22:48:44.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>08805116000119</udiDi>
    <basicUdiDi>B-08805116000119</basicUdiDi>
    <tradeName>ACCUNIQ BC720</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SELVAS Healthcare, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019198</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099001</emdnCode>
    <emdnDescription>BODY IMPEDANCE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACCUNIQ BC720_Catalog</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:07:22.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260179765766</udiDi>
    <basicUdiDi>426017976CSXJG</basicUdiDi>
    <tradeName>CeCon 4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DWA Dialyse Wasser Aufbereitungsanlagen GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000008370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12099006</emdnCode>
    <emdnDescription>LIQUID DIALYSIS PREPARATIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03CE43012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:46:27.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260179765773</udiDi>
    <basicUdiDi>426017976CSXJG</basicUdiDi>
    <tradeName>CeCon 4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DWA Dialyse Wasser Aufbereitungsanlagen GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000008370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12099006</emdnCode>
    <emdnDescription>LIQUID DIALYSIS PREPARATIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03CE43013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:46:27.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-054300042040086T</udiDi>
    <basicUdiDi>B-054300042040086T</basicUdiDi>
    <tradeName>D-054300042040086T</tradeName>
    <deviceName>NephroFlow Kt/V module</deviceName>
    <manufacturerName>Nipro Digital Technologies Europe NV</manufacturerName>
    <manufacturerSrn>BE-MF-000043005</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12099092</emdnCode>
    <emdnDescription>VARIOUS NEPHROLOGY AND HAEMODIALYSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Kt/V module V1.0.2</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:44:22.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719326710709</udiDi>
    <basicUdiDi>871932671071101100L2</basicUdiDi>
    <tradeName>Diamant</tradeName>
    <deviceName>Diamant</deviceName>
    <manufacturerName>Diasoft B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000001563</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12099082</emdnCode>
    <emdnDescription>VARIOUS NEPHROLOGY AND HAEMODIALYSIS INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11.01.100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:35:15.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697595121627</udiDi>
    <basicUdiDi>869759512BAMBINO2U</basicUdiDi>
    <tradeName>Kenmak Hastane Malzemeleri</tradeName>
    <deviceName>CHILD COT WİTH (ELECTRİC LENGTH EXTENSİON)</deviceName>
    <manufacturerName>Kenmak Hastane Malzemeleri</manufacturerName>
    <manufacturerSrn>TR-MF-000016184</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12099003</emdnCode>
    <emdnDescription>HOSPITAL BEDS OR ARMCHAIR SCALES FOR DIALYSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAMBINO</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:44:26.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682157008003</udiDi>
    <basicUdiDi>8682157008RIVAMEDRO6M</basicUdiDi>
    <tradeName>RİVAMED RM 100 Hemodialysis Reverse Osmosis Water Treatment System</tradeName>
    <deviceName>Hemodialysis Reverse Osmosis Water Treatment System</deviceName>
    <manufacturerName>Riva Muhendislik Su Aritma Sistemleri Ltd Şti</manufacturerName>
    <manufacturerSrn>TR-MF-000044532</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12099007</emdnCode>
    <emdnDescription>DIALYSIS WATER TREATMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RM 100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:42:40.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594212440164</udiDi>
    <basicUdiDi>859421244BIOMHL</basicUdiDi>
    <tradeName>BIOM 7.8</tradeName>
    <deviceName>BIOM 7.8</deviceName>
    <manufacturerName>EKOVUK MEDI, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000040403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12099001</emdnCode>
    <emdnDescription>BODY IMPEDANCE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIOM 7.8</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:51:42.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059575420159</udiDi>
    <basicUdiDi>805957542RO2MDTP5</basicUdiDi>
    <tradeName>08059575420159</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grundfos Water Treatment Italy S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000041478</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12099007</emdnCode>
    <emdnDescription>DIALYSIS WATER TREATMENT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>763766</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:28:14.335Z</lastUpdated>
  </row>
</eudamedExport>