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    <tradeName>Filterkassette 15/22 mm für PRIMEDI-PHON PLUS® unsteril</tradeName>
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    <tradeName>PRIMEDI-PHON Sprechventil für Tracheotomierte,</tradeName>
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    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2001 (Purple Color™)</tradeName>
    <deviceName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2001 (Purple Color™)</deviceName>
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    <basicUdiDi>0859760005PMV2000J4</basicUdiDi>
    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2000 (clear)</tradeName>
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    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY SWALLOWING AND SPEAKING VALVE PMV™ 2020 (clear)</tradeName>
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    <lastUpdated>2026-07-30T17:25:20.392Z</lastUpdated>
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    <tradeName>PASSY-MUIR™ TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 005 (white)</tradeName>
    <deviceName>PASSY-MUIR™ TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 005 (white)</deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
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    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 005</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:19.588Z</lastUpdated>
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    <tradeName>SPIRO</tradeName>
    <deviceName>Speaking Valve with oxygen nipple</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710R-5K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:59:57.505Z</lastUpdated>
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    <tradeName>SPIRO</tradeName>
    <deviceName>Speaking Valve with oxygen nipple</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
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    <tradeName>SPIRO</tradeName>
    <deviceName>Speaking Valve with oxygen nipple</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
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    <emdnCode>R90060202</emdnCode>
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    <tradeName>SPIRO</tradeName>
    <deviceName>Speaking Valve with oxygen nipple</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
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    <reference>710-5K</reference>
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    <tradeName>SPIRO</tradeName>
    <deviceName>Speaking Valve with oxygen nipple</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
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    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
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    <tradeName>SPIRO</tradeName>
    <deviceName>Speaking Valve with oxygen nipple</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
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    <tradeName>SPIRO</tradeName>
    <deviceName>Speaking Valve with oxygen nipple</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
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    <reference>710R-5K</reference>
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    <lastUpdated>2026-07-11T13:17:45.411Z</lastUpdated>
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    <tradeName>SPIRO</tradeName>
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    <manufacturerName>Fogless International AB</manufacturerName>
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    <tradeName>SPIRO</tradeName>
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    <tradeName>SPIRO</tradeName>
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    <manufacturerName>Fogless International AB</manufacturerName>
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    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
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    <tradeName>SPIRO</tradeName>
    <deviceName>Speaking Valve with oxygen nipple</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
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    <tradeName>SPIRO</tradeName>
    <deviceName>Speaking Valve with oxygen nipple</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
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