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<eudamedExport entity="devices">
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    <basicUdiDi>B-00810032661670</basicUdiDi>
    <tradeName>Posterior Mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIL0250-DE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:42.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661632</udiDi>
    <basicUdiDi>B-00810032661632</basicUdiDi>
    <tradeName>Posterior Mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIL0250-POL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:42.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661618</udiDi>
    <basicUdiDi>B-00810032661618</basicUdiDi>
    <tradeName>Posterior Mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIL0250-GRC</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:38.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661588</udiDi>
    <basicUdiDi>B-00810032661588</basicUdiDi>
    <tradeName>Posterior Mouthpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIL0250-BEN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:22.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661571</udiDi>
    <basicUdiDi>B-00810032661571</basicUdiDi>
    <tradeName>Isovac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIV0108-DE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:22.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661533</udiDi>
    <basicUdiDi>B-00810032661533</basicUdiDi>
    <tradeName>Isovac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIV0108-POL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:21.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661519</udiDi>
    <basicUdiDi>B-00810032661519</basicUdiDi>
    <tradeName>Isovac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIV0108-GRC</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:20.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661489</udiDi>
    <basicUdiDi>B-00810032661489</basicUdiDi>
    <tradeName>Isovac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIV0108-BEN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:16.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661472</udiDi>
    <basicUdiDi>B-00810032661472</basicUdiDi>
    <tradeName>Isovac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIV0107-DE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:15.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661434</udiDi>
    <basicUdiDi>B-00810032661434</basicUdiDi>
    <tradeName>Isovac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIV0107-POL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:14.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661410</udiDi>
    <basicUdiDi>B-00810032661410</basicUdiDi>
    <tradeName>Isovac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIV0107-GRC</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:14.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661380</udiDi>
    <basicUdiDi>B-00810032661380</basicUdiDi>
    <tradeName>Isovac</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIV0107-BEN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:10.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661311</udiDi>
    <basicUdiDi>B-00810032661311</basicUdiDi>
    <tradeName>Isolite, i3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIL0302-POL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:09.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661298</udiDi>
    <basicUdiDi>B-00810032661298</basicUdiDi>
    <tradeName>Isolite, i3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIL0302-GRC</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:08.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661267</udiDi>
    <basicUdiDi>B-00810032661267</basicUdiDi>
    <tradeName>Isolite, i3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIL0302-BEN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:07.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661090</udiDi>
    <basicUdiDi>B-00810032661090</basicUdiDi>
    <tradeName>Isolite, i3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIL0302-DE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:03.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032661069</udiDi>
    <basicUdiDi>B-00810032661069</basicUdiDi>
    <tradeName>00810032661069</tradeName>
    <deviceName>Lever Set, Isovac</deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIV0102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:02.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660956</udiDi>
    <basicUdiDi>B-00810032660956</basicUdiDi>
    <tradeName>00810032660956</tradeName>
    <deviceName>Vacuum Light Pipe, Si, i3</deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIL0323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:02.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660949</udiDi>
    <basicUdiDi>B-00810032660949</basicUdiDi>
    <tradeName>00810032660949</tradeName>
    <deviceName>Fitting, 0.25 BSP Spiral, i3</deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIL0322</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:53:01.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660901</udiDi>
    <basicUdiDi>B-00810032660901</basicUdiDi>
    <tradeName>00810032660901</tradeName>
    <deviceName>Power Adaptor, EU, 4.5m, i3</deviceName>
    <manufacturerName>Zyris, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034843</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019001</emdnCode>
    <emdnDescription>SALIVA ASPIRATORS AND SALIVA ABSORBENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIL0318</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:57.263Z</lastUpdated>
  </row>
</eudamedExport>