<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00896506002071</udiDi>
    <basicUdiDi>B-00896506002071</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Deployment Catheter and Loader</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-C26N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:13.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896506002064</udiDi>
    <basicUdiDi>B-00896506002064</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Valve in Cartridge</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-V9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:12.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896506002057</udiDi>
    <basicUdiDi>B-00896506002057</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Deployment Catheter and Loader</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-C20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:11.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896506002040</udiDi>
    <basicUdiDi>B-00896506002040</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Airway Sizing Kit</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-VSK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:11.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896506002026</udiDi>
    <basicUdiDi>B-00896506002026</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Valve in Cartridge</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-V5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:07.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896506002019</udiDi>
    <basicUdiDi>B-00896506002019</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Valve in Cartridge</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-V6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:06.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896506002002</udiDi>
    <basicUdiDi>B-00896506002002</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Valve in Cartridge</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-V7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:05.504Z</lastUpdated>
  </row>
</eudamedExport>