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    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Antistatische voorzetkamer - Mondstuk voor kinderen</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <lastUpdated>2026-07-04T15:32:16.580Z</lastUpdated>
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    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AeroChamber Plus* Flow-Vu*, 5+ Years Youth</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>108509/108509110060</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Anti-statisk ventileret kammer – Ungdom - 5+ år Antistaattinen venttiilillinen tilanjatke – Nuori - 5+ vuotta</deviceName>
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    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>108509/108509109060</reference>
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    <lastUpdated>2026-07-04T15:32:11.757Z</lastUpdated>
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    <basicUdiDi>B-00762860501782</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Anti-statisk ventileret kammer - Voksen – Mundstykke Antistaattinen venttiilillinen tilanjatke – Aikuinen - Suukappale Antistatisk inhalasjonskammer med ventil - Voksen – Munnstykke Antistatisk andn</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>108501/108501109060</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:32:10.970Z</lastUpdated>
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    <udiDi>00762860235014</udiDi>
    <basicUdiDi>B-00762860235014</basicUdiDi>
    <tradeName>AeroChamber2go*</tradeName>
    <deviceName>AeroChamber2go* Anti-Static 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>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>123501</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:32:10.178Z</lastUpdated>
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    <basicUdiDi>B-00762860191099</basicUdiDi>
    <tradeName>AeroChamber Plus*</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>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101501</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:32:06.161Z</lastUpdated>
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    <basicUdiDi>B-00762860110304</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Antistatische voorzetkamer - Voor volwassenen - Mondstuk</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>108501/10850184060</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:32:05.353Z</lastUpdated>
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    <udiDi>00762860105027</udiDi>
    <basicUdiDi>B-00762860105027</basicUdiDi>
    <tradeName>Aerobika</tradeName>
    <deviceName>Aerobika* Oscillating Positive Expiratory Pressure Device with Manometer Accessory</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>110501 110502/11050491010</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:32:04.557Z</lastUpdated>
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  <row>
    <udiDi>00762860055155</udiDi>
    <basicUdiDi>B-00762860055155</basicUdiDi>
    <tradeName>Ombra*</tradeName>
    <deviceName>Ombra* Table Top Compressor, 230 Volt G Plug</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105515</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:32:03.749Z</lastUpdated>
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    <udiDi>00762860055117</udiDi>
    <basicUdiDi>B-00762860055117</basicUdiDi>
    <tradeName>Ombra*</tradeName>
    <deviceName>Ombra* Table Top Compressor, 230 Volt Euro Plug</deviceName>
    <manufacturerName>Trudell Medical International</manufacturerName>
    <manufacturerSrn>CA-MF-000009860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R060101</emdnCode>
    <emdnDescription>COLD NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105511</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:59.770Z</lastUpdated>
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    <udiDi>00762860015012</udiDi>
    <basicUdiDi>B-00762860015012</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS</tradeName>
    <deviceName>AeroChamber Plus* Adult Mouthpiece</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>101501 / 101501100070</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:58.948Z</lastUpdated>
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    <udiDi>00762860013537</udiDi>
    <basicUdiDi>B-00762860013537</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AEROCHAMBER PLUS* FLOW-VU* Adult Mouthpiece</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 / 108501110060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:58.146Z</lastUpdated>
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  <row>
    <udiDi>00762860001930</udiDi>
    <basicUdiDi>B-00762860001930</basicUdiDi>
    <tradeName>AEROBIKA</tradeName>
    <deviceName>Manometer Accessory for use with 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>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110502/11050291001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:57.375Z</lastUpdated>
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    <udiDi>00762860001466</udiDi>
    <basicUdiDi>B-00762860001466</basicUdiDi>
    <tradeName>AEROCHAMBER2GO*</tradeName>
    <deviceName>AEROCHAMBER2GO* Anti-Static Valved Holding Chamber for use with Metered Dose Inhalers</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>123501/123501127060</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:53.352Z</lastUpdated>
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    <udiDi>00762860001459</udiDi>
    <basicUdiDi>B-00762860001459</basicUdiDi>
    <tradeName>AEROCHAMBER2GO*</tradeName>
    <deviceName>AEROCHAMBER2GO* Anti-Static Valved Holding Chamber for use with Metered Dose Inhalers</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>123501/123501126060</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:52.540Z</lastUpdated>
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    <udiDi>00762860001435</udiDi>
    <basicUdiDi>B-00762860001435</basicUdiDi>
    <tradeName>AEROCHAMBER2GO*</tradeName>
    <deviceName>AEROCHAMBER2GO* 2-in-1 Chamber + Protective Case for use with Metered Dose Inhalers</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>123501/123501129060</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:51.739Z</lastUpdated>
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    <udiDi>00762860000667</udiDi>
    <basicUdiDi>B-00762860000667</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AeroChamber Plus* Flow-Vu* 5+ years Youth Mouthpiece</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>108509/108509119070</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:50.938Z</lastUpdated>
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    <udiDi>00762860000650</udiDi>
    <basicUdiDi>B-00762860000650</basicUdiDi>
    <tradeName>AEROCHAMBER PLUS FLOW-VU</tradeName>
    <deviceName>AeroChamber Plus* Flow-Vu* Adult Mouthpiece</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>108501/108501119070</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:46.934Z</lastUpdated>
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    <udiDi>00762860000421</udiDi>
    <basicUdiDi>B-00762860000421</basicUdiDi>
    <tradeName>RespiChamber</tradeName>
    <deviceName>RespiChamber*  Autoclavable Valved Holding Chamber for use with Metered Dose Inhalers</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>113505/113505110120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:46.138Z</lastUpdated>
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    <basicUdiDi>B-00762860000414</basicUdiDi>
    <tradeName>RESPICHAMBER</tradeName>
    <deviceName>RespiChamber* Static -Resistant Valved Holding Chamber For use with Metered Dose Inhalers</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>113501/113501110120</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:45.338Z</lastUpdated>
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