<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>00810032660802</udiDi>
    <basicUdiDi>B-00810032660802</basicUdiDi>
    <tradeName>00810032660802</tradeName>
    <deviceName>Vacuum Lever Set, 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>PIL0306</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:56.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660666</udiDi>
    <basicUdiDi>B-00810032660666</basicUdiDi>
    <tradeName>00810032660666</tradeName>
    <deviceName>Connector, Euro HVE to 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>AIL0248</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:55.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660611</udiDi>
    <basicUdiDi>B-00810032660611</basicUdiDi>
    <tradeName>00810032660611</tradeName>
    <deviceName>Connector, Kavo to 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>AIL0237</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:54.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660604</udiDi>
    <basicUdiDi>B-00810032660604</basicUdiDi>
    <tradeName>00810032660604</tradeName>
    <deviceName>Connector, 11mm Saliva Ejector Base to 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>AIL0236</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:50.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660598</udiDi>
    <basicUdiDi>B-00810032660598</basicUdiDi>
    <tradeName>00810032660598</tradeName>
    <deviceName>Connector, XO Care to 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>AIL0235</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:50.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660581</udiDi>
    <basicUdiDi>B-00810032660581</basicUdiDi>
    <tradeName>00810032660581</tradeName>
    <deviceName>Connector, Heka to 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>AIL0234</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:49.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660574</udiDi>
    <basicUdiDi>B-00810032660574</basicUdiDi>
    <tradeName>00810032660574</tradeName>
    <deviceName>Connector, Sirona to 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>AIL0233</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:48.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660567</udiDi>
    <basicUdiDi>B-00810032660567</basicUdiDi>
    <tradeName>00810032660567</tradeName>
    <deviceName>Connector, 11mm SE Control Head to 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>AIL0232</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:44.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660239</udiDi>
    <basicUdiDi>B-00810032660239</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>CIL1101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:43.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810032660208</udiDi>
    <basicUdiDi>B-00810032660208</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>CIL0901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:52:42.873Z</lastUpdated>
  </row>
</eudamedExport>