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    <manufacturerName>Fogless International AB</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:00:02.300Z</lastUpdated>
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    <tradeName>SPIRO</tradeName>
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    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>PHONATION VALVES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:59:58.315Z</lastUpdated>
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    <basicUdiDi>B-47350061230122</basicUdiDi>
    <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>
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    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
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    <reference>710R-5K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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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>
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    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>710R-2K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:59:56.709Z</lastUpdated>
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    <udiDi>47350061230108</udiDi>
    <basicUdiDi>B-47350061230108</basicUdiDi>
    <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-1K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:59:55.904Z</lastUpdated>
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    <udiDi>47350061230092</udiDi>
    <basicUdiDi>B-47350061230092</basicUdiDi>
    <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>710-5K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:59:51.909Z</lastUpdated>
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    <udiDi>47350061230085</udiDi>
    <basicUdiDi>B-47350061230085</basicUdiDi>
    <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>710-2K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:59:51.104Z</lastUpdated>
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    <udiDi>47350061230078</udiDi>
    <basicUdiDi>B-47350061230078</basicUdiDi>
    <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>710-1K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:59:50.307Z</lastUpdated>
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    <udiDi>47350061230023</udiDi>
    <basicUdiDi>B-47350061230023</basicUdiDi>
    <tradeName>SPIRO</tradeName>
    <deviceName>Humidifier</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>702-5K</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:59:49.507Z</lastUpdated>
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    <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>27350061230180</udiDi>
    <basicUdiDi>B-27350061230180</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>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-100K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:47.801Z</lastUpdated>
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    <udiDi>27350061230128</udiDi>
    <basicUdiDi>B-27350061230128</basicUdiDi>
    <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>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:45.411Z</lastUpdated>
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    <udiDi>27350061230111</udiDi>
    <basicUdiDi>B-27350061230111</basicUdiDi>
    <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-2K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:43.810Z</lastUpdated>
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    <udiDi>27350061230104</udiDi>
    <basicUdiDi>B-27350061230104</basicUdiDi>
    <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-1K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:41.484Z</lastUpdated>
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    <udiDi>27350061230098</udiDi>
    <basicUdiDi>B-27350061230098</basicUdiDi>
    <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>710-5K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:39.781Z</lastUpdated>
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    <udiDi>27350061230081</udiDi>
    <basicUdiDi>B-27350061230081</basicUdiDi>
    <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>710-2K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:39.007Z</lastUpdated>
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    <udiDi>27350061230074</udiDi>
    <basicUdiDi>B-27350061230074</basicUdiDi>
    <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>710-1K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:37.579Z</lastUpdated>
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    <udiDi>27350061230029</udiDi>
    <basicUdiDi>B-27350061230029</basicUdiDi>
    <tradeName>SPIRO</tradeName>
    <deviceName>Humidifier</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>702-5K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:34.996Z</lastUpdated>
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    <udiDi>07350061230001</udiDi>
    <basicUdiDi>B-07350061230001</basicUdiDi>
    <tradeName>SPIRO Humidifier</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>702</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:16:27.004Z</lastUpdated>
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    <tradeName>SPIRO</tradeName>
    <deviceName>Tweezers</deviceName>
    <manufacturerName>Fogless International AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001616</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L031305</emdnCode>
    <emdnDescription>FORCEPS FOR FABRICS AND BANDAGES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>705-5K</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:02:54.613Z</lastUpdated>
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