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    <tradeName>00762860000377</tradeName>
    <deviceName>SMART SPACER</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>124501/12450191024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:44.539Z</lastUpdated>
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    <udiDi>00762860000230</udiDi>
    <basicUdiDi>B-00762860000230</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Antistatische Inhalierhilfe – Erwachsene Mundstück Unverkäufliches Muster</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108501/108501117050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:40.538Z</lastUpdated>
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    <udiDi>00762860000346</udiDi>
    <basicUdiDi>B-00762860000346</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Cámara Antiestática de Retención con Válvula - Boquilla  Câmara de Retenção Antiestática com Válvula - Bocal</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108501/108501114060</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:39.727Z</lastUpdated>
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    <udiDi>00762860000247</udiDi>
    <basicUdiDi>B-00762860000247</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Antistatische Inhalierhilfe – Jugend Unverkäufliches Muster</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108509/108509117050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:38.932Z</lastUpdated>
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    <udiDi>00762860000186</udiDi>
    <basicUdiDi>B-00762860000186</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Antistatische Inhalierhilfe - Jugend</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108509/108509115050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:38.134Z</lastUpdated>
  </row>
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    <udiDi>00762860000179</udiDi>
    <basicUdiDi>B-00762860000179</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Antistatische Inhalierhilfe – Erwachsene Mundstück</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108501/108501115050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:22.065Z</lastUpdated>
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    <udiDi>00762860000124</udiDi>
    <basicUdiDi>B-00762860000124</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Antistatische Inhalierhilfe - Jugend</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108509/108509115060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:21.263Z</lastUpdated>
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    <udiDi>00762860000117</udiDi>
    <basicUdiDi>B-00762860000117</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Antistatische Inhalierhilfe – Erwachsene Mundstück</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108501/108501115060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:19.666Z</lastUpdated>
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    <udiDi>00762860000063</udiDi>
    <basicUdiDi>B-00762860000063</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AeroChamber Plus* Flow-Vu* Youth Mouthpiece 5+yrs Sample- Not For Sale</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108509/10850982050</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:17.262Z</lastUpdated>
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    <udiDi>00762860000056</udiDi>
    <basicUdiDi>B-00762860000056</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Mouthpiece 5+ years SAMPLE - NOT FOR SALE</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108501/10850182050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:15.678Z</lastUpdated>
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    <udiDi>00762860000834</udiDi>
    <basicUdiDi>762860NEB1LA</basicUdiDi>
    <tradeName>COMFORTSEAL*</tradeName>
    <deviceName>Accessory to AeroEclipse* BAN* Nebulizer</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0680</emdnCode>
    <emdnDescription>NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105503/105503110010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:06:41.495Z</lastUpdated>
  </row>
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    <udiDi>00762860000827</udiDi>
    <basicUdiDi>762860MVENT1FT</basicUdiDi>
    <tradeName>AeroChamber*</tradeName>
    <deviceName>AeroChamber* MV Holding Chamber</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82591</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:06:40.670Z</lastUpdated>
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    <udiDi>00762860000803</udiDi>
    <basicUdiDi>762860MINI1EM</basicUdiDi>
    <tradeName>AeroChamber*</tradeName>
    <deviceName>AeroChamber* mini Anti-Static Holding Chamber</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>87501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:06:36.684Z</lastUpdated>
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    <udiDi>00762860000681</udiDi>
    <basicUdiDi>762860OPEP1G4</basicUdiDi>
    <tradeName>Aerobika</tradeName>
    <deviceName>Aerobika* Oscillating Positive Expiratory Pressure Device</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110501/11050191010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:06:35.875Z</lastUpdated>
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    <udiDi>00762860000018</udiDi>
    <basicUdiDi>762860VHC1NL</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>Valved Holding Chamber</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108507/10850782080</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:06:35.090Z</lastUpdated>
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    <udiDi>00762860000001</udiDi>
    <basicUdiDi>762860VENT1HV</basicUdiDi>
    <tradeName>AeroChamber*</tradeName>
    <deviceName>AeroChamber* VENT Holding Chamber</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85851</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:06:34.316Z</lastUpdated>
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    <udiDi>00762860000025</udiDi>
    <basicUdiDi>762860VHC1NL</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108502/10850282080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:38:59.405Z</lastUpdated>
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    <udiDi>00762860000032</udiDi>
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    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108508/10850882050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:38:59.389Z</lastUpdated>
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    <basicUdiDi>762860VHC1NL</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108504/10850482050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:38:59.368Z</lastUpdated>
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    <basicUdiDi>762860VHC1NL</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108507/108507115070</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:38:59.309Z</lastUpdated>
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