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    <tradeName>Passy-Muir™ Valve Oxygen Adapter (PMA™ 2000)</tradeName>
    <deviceName>Passy-Muir™ Valve Oxygen Adapter (PMA™ 2000)</deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R900680</emdnCode>
    <emdnDescription>PHONATION VALVES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMA 2000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:25.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>47350061230177</udiDi>
    <basicUdiDi>B-47350061230177</basicUdiDi>
    <tradeName>SPIRO</tradeName>
    <deviceName>Filter</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R900680</emdnCode>
    <emdnDescription>PHONATION VALVES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-25K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:59:58.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>27350061230173</udiDi>
    <basicUdiDi>B-27350061230173</basicUdiDi>
    <tradeName>SPIRO</tradeName>
    <deviceName>Filter</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R900680</emdnCode>
    <emdnDescription>PHONATION VALVES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-25K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:50.682Z</lastUpdated>
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    <udiDi>17350061230343</udiDi>
    <basicUdiDi>73500612300779</basicUdiDi>
    <tradeName>SPIRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900680</emdnCode>
    <emdnDescription>PHONATION VALVES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>730-2K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:01:25.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>27350061230234</udiDi>
    <basicUdiDi>73500612300779</basicUdiDi>
    <tradeName>SPIRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900680</emdnCode>
    <emdnDescription>PHONATION VALVES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>730-2K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:19:54.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>47350061230238</udiDi>
    <basicUdiDi>73500612300779</basicUdiDi>
    <tradeName>SPIRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R900680</emdnCode>
    <emdnDescription>PHONATION VALVES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>730-2K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:23:14.925Z</lastUpdated>
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