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    <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>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>10889483586532</udiDi>
    <basicUdiDi>B-10889483586532</basicUdiDi>
    <tradeName>AirLife™ EdithTrach HME for Spontaneously Breathing Patients, Disposable</tradeName>
    <deviceName>AirLife™ Humidification and Filtration</deviceName>
    <manufacturerName>AirLife Finland Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001482</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>557005000</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:34:27.387Z</lastUpdated>
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    <udiDi>10190752139992</udiDi>
    <basicUdiDi>B-10190752139992</basicUdiDi>
    <tradeName>AirLife™ EdithTrach HME for Spontaneously Breathing Patients, Disposable</tradeName>
    <deviceName>AirLife™ Humidification and Filtration</deviceName>
    <manufacturerName>AirLife Finland Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001482</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>557005000</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:50:14.644Z</lastUpdated>
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    <udiDi>08033860038748</udiDi>
    <basicUdiDi>B-08033860038748</basicUdiDi>
    <tradeName>MEDISIZE HUMITRACH</tradeName>
    <deviceName>MEDISIZE HUMITRACH</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300740000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:50:45.748Z</lastUpdated>
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    <udiDi>08033860016111</udiDi>
    <basicUdiDi>B-08033860016111</basicUdiDi>
    <tradeName>EASY BREATH</tradeName>
    <deviceName>EASY BREATH</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK008BN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:33:29.361Z</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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    <udiDi>07331826002347</udiDi>
    <basicUdiDi>B-07331826002347</basicUdiDi>
    <tradeName>EURO LifeSupport</tradeName>
    <deviceName>HME Trach Oxygen 6mm</deviceName>
    <manufacturerName>Aktiebolaget Ulax</manufacturerName>
    <manufacturerSrn>SE-MF-000023034</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6010</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:58:55.664Z</lastUpdated>
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    <udiDi>07331826002354</udiDi>
    <basicUdiDi>B-07331826002354</basicUdiDi>
    <tradeName>EURO LifeSupport</tradeName>
    <deviceName>HME Trach 6060</deviceName>
    <manufacturerName>Aktiebolaget Ulax</manufacturerName>
    <manufacturerSrn>SE-MF-000023034</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6060</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:58:51.739Z</lastUpdated>
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    <udiDi>07331826000275</udiDi>
    <basicUdiDi>B-07331826000275</basicUdiDi>
    <tradeName>EURO LifeSupport</tradeName>
    <deviceName>HME Trach</deviceName>
    <manufacturerName>Aktiebolaget Ulax</manufacturerName>
    <manufacturerSrn>SE-MF-000023034</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6000</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:58:33.657Z</lastUpdated>
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    <udiDi>04250203210690</udiDi>
    <basicUdiDi>42502032PRI0244N</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -O2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20486</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:52.402Z</lastUpdated>
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    <udiDi>04250203210706</udiDi>
    <basicUdiDi>42502032PRI0244N</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -NATAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20496</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:52.382Z</lastUpdated>
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    <udiDi>04250203210713</udiDi>
    <basicUdiDi>42502032PRI0244N</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -DUAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20497</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:52.362Z</lastUpdated>
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    <udiDi>04250203212564</udiDi>
    <basicUdiDi>42502032PRI0244N</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -LATERAL 15</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20492</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:51.830Z</lastUpdated>
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    <udiDi>04250203212571</udiDi>
    <basicUdiDi>42502032PRI0244N</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -LATERAL 15 S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20493</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:51.811Z</lastUpdated>
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    <basicUdiDi>42502032PRI0244N</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -LATERAL 22</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20494</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:51.794Z</lastUpdated>
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    <basicUdiDi>42502032PRI0244N</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -LATERAL 22 S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20495</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:51.773Z</lastUpdated>
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    <udiDi>04048675420897</udiDi>
    <basicUdiDi>B-04048675420897</basicUdiDi>
    <tradeName>HME HumidStar trach.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MP01750</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:00:09.435Z</lastUpdated>
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    <tradeName>00841737101352</tradeName>
    <deviceName>Precision Flow Heliox Unit</deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PFH-UNIT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:46.714Z</lastUpdated>
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    <tradeName>Precision Flow</tradeName>
    <deviceName>Precision Flow Plus</deviceName>
    <manufacturerName>Vapotherm Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006231</manufacturerSrn>
    <authorisedRepresentativeName>AJW Technology Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004999</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF-PLUS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:45.145Z</lastUpdated>
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