<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00038214000080</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Mark 5 Nuvo Lite 3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>935</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214000233</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Mark 5 Nuvo 8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>985</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214000882</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Mark 5 Nuvo Lite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>925NEB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214000974</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Mark 5 Nuvo Lite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>925Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214001179</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Mark 5 Nuvo Lite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>925UK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214001193</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Mark 5 Nuvo 8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>985UK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214001360</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Mark 5 Nuvo 10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214001469</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Mark 5 Nuvo 10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005UK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214001520</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Mark 5 Nuvo Lite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>925-OCSI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214001636</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Max 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214001698</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Mark 5 Nuvo 10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005/60</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214001742</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Max 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3005UK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214001896</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Max 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3005IS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214002466</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Nuvo Nano</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>855</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>00038214002923</udiDi>
    <basicUdiDi>00038214NIDEK4L</basicUdiDi>
    <tradeName>Mark 5 Nuvo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nidek Medical Products Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007253</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>965</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:12:12.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190707057213</udiDi>
    <basicUdiDi>0190707O2ElastAttachersZP</basicUdiDi>
    <tradeName>Elastic Attachers</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho Organizers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010061</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>402-010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:49.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190707083847</udiDi>
    <basicUdiDi>0190707O2ReliefWaxVL</basicUdiDi>
    <tradeName>Orthodontic Relief Wax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho Organizers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010061</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:49.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190707083854</udiDi>
    <basicUdiDi>0190707O2ReliefWaxVL</basicUdiDi>
    <tradeName>Orthodontic Relief Wax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho Organizers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010061</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-030BG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:49.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190707083861</udiDi>
    <basicUdiDi>0190707O2ReliefWaxVL</basicUdiDi>
    <tradeName>Orthodontic Relief Wax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho Organizers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010061</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-030C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:49.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190707083878</udiDi>
    <basicUdiDi>0190707O2ReliefWaxVL</basicUdiDi>
    <tradeName>Orthodontic Relief Wax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho Organizers, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010061</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-030L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:10:49.090Z</lastUpdated>
  </row>
</eudamedExport>