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    <tradeName>Archimedes® System</tradeName>
    <deviceName>Archimedes Lite</deviceName>
    <manufacturerName>Broncus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027543</manufacturerSrn>
    <authorisedRepresentativeName>MedDevConsult GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005877</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42105</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:08.917Z</lastUpdated>
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    <udiDi>00856571007272</udiDi>
    <basicUdiDi>B-00856571007272</basicUdiDi>
    <tradeName>Archimedes® Lite</tradeName>
    <deviceName>Archimedes Lite</deviceName>
    <manufacturerName>Broncus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027543</manufacturerSrn>
    <authorisedRepresentativeName>MedDevConsult GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005877</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0799</emdnCode>
    <emdnDescription>BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:07.327Z</lastUpdated>
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    <udiDi>00856571007265</udiDi>
    <basicUdiDi>B-00856571007265</basicUdiDi>
    <tradeName>EasyPath® RF Introducer Sheath</tradeName>
    <deviceName>EasyPath RF Introducer Sheath</deviceName>
    <manufacturerName>Broncus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027543</manufacturerSrn>
    <authorisedRepresentativeName>MedDevConsult GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005877</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0799</emdnCode>
    <emdnDescription>BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:06.509Z</lastUpdated>
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    <udiDi>00856571007210</udiDi>
    <basicUdiDi>B-00856571007210</basicUdiDi>
    <tradeName>FleXNeedle® Transbronchial Aspiration Needle</tradeName>
    <deviceName>FleXNeedle® Transbronchial Aspiration Needle</deviceName>
    <manufacturerName>Broncus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027543</manufacturerSrn>
    <authorisedRepresentativeName>MedDevConsult GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005877</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010207</emdnCode>
    <emdnDescription>PULMONARY BIOPSY NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10005-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:04.928Z</lastUpdated>
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    <udiDi>00856571007104</udiDi>
    <basicUdiDi>B-00856571007104</basicUdiDi>
    <tradeName>Archimedes® System</tradeName>
    <deviceName>Archimedes Planner</deviceName>
    <manufacturerName>Broncus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027543</manufacturerSrn>
    <authorisedRepresentativeName>MedDevConsult GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005877</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0799</emdnCode>
    <emdnDescription>BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:02.546Z</lastUpdated>
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    <udiDi>00856571007074</udiDi>
    <basicUdiDi>B-00856571007074</basicUdiDi>
    <tradeName>Archimedes Dilation Balloon</tradeName>
    <deviceName>Archimedes Balloon</deviceName>
    <manufacturerName>Broncus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027543</manufacturerSrn>
    <authorisedRepresentativeName>MedDevConsult GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005877</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0799</emdnCode>
    <emdnDescription>BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:00.915Z</lastUpdated>
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    <udiDi>00856571007067</udiDi>
    <basicUdiDi>B-00856571007067</basicUdiDi>
    <tradeName>Archimedes Sheath</tradeName>
    <deviceName>Archimedes Sheath</deviceName>
    <manufacturerName>Broncus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027543</manufacturerSrn>
    <authorisedRepresentativeName>MedDevConsult GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005877</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0799</emdnCode>
    <emdnDescription>BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:00.109Z</lastUpdated>
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    <udiDi>00856571007036</udiDi>
    <basicUdiDi>B-00856571007036</basicUdiDi>
    <tradeName>Archimedes® System</tradeName>
    <deviceName>Archimedes System</deviceName>
    <manufacturerName>Broncus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027543</manufacturerSrn>
    <authorisedRepresentativeName>MedDevConsult GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005877</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0799</emdnCode>
    <emdnDescription>BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:32:58.509Z</lastUpdated>
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    <udiDi>00856571007029</udiDi>
    <basicUdiDi>B-00856571007029</basicUdiDi>
    <tradeName>Archimedes Access Kit</tradeName>
    <deviceName>Archimedes Access Kit</deviceName>
    <manufacturerName>Broncus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027543</manufacturerSrn>
    <authorisedRepresentativeName>MedDevConsult GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005877</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010207</emdnCode>
    <emdnDescription>PULMONARY BIOPSY NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:32:56.108Z</lastUpdated>
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    <udiDi>00856571007012</udiDi>
    <basicUdiDi>B-00856571007012</basicUdiDi>
    <tradeName>FleXNeedle® Transbronchial Aspiration Needle</tradeName>
    <deviceName>FleXNeedle® Transbronchial Aspiration Needle</deviceName>
    <manufacturerName>Broncus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027543</manufacturerSrn>
    <authorisedRepresentativeName>MedDevConsult GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005877</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010207</emdnCode>
    <emdnDescription>PULMONARY BIOPSY NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10005-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:32:54.538Z</lastUpdated>
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