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    <deviceName>Provox LaryClip</deviceName>
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    <deviceName>Provox TubeHolder</deviceName>
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    <tradeName>Tracheostomy Tube</tradeName>
    <deviceName>Tracheostomy Tube</deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
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    <basicUdiDi>697299186CA1301F5</basicUdiDi>
    <tradeName>Tracheostomy Tube</tradeName>
    <deviceName>Tracheostomy Tube</deviceName>
    <manufacturerName>MEDCAPTAIN LIFE SCIENCE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000006656</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>BM Tracheostomy Tube with Inner Cannula</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>224 50 00 2</reference>
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    <tradeName>BM Reinforced Tracheostomy Tubes</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <tradeName>BM Reinforced Tracheostomy Tube with Evacuation Lumen</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:57.694Z</lastUpdated>
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    <tradeName>BM Tracheostomy Tube with Evacuation Lumen</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225 50 00 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:56.076Z</lastUpdated>
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    <udiDi>06972091927402</udiDi>
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    <tradeName>BM Reinforced Tracheostomy Tubes</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnCode>R0105020201</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>226 50 00 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:55.275Z</lastUpdated>
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    <udiDi>06972091921332</udiDi>
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    <tradeName>BM Tracheostomy Tubes</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22330002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:20.019Z</lastUpdated>
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    <udiDi>06972091921189</udiDi>
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    <tradeName>BM Tracheostomy Tubes</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Bonree Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017844</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222 30 00 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:19.194Z</lastUpdated>
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    <tradeName>EVO-FIX Jednoczęściowe mocowanie rurki tracheostomijnej</tradeName>
    <deviceName>EVO-FIX Opaska do mocowania rurek tracheostomijnych</deviceName>
    <manufacturerName>SINMED SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ</manufacturerName>
    <manufacturerSrn>PL-MF-000002789</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058001</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020011</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:36:41.056Z</lastUpdated>
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    <tradeName>TraxGuard Tracheostomy and Laryngectomy Protector. Large White</tradeName>
    <deviceName>TraxGuard Tracheostomy and Laryngectomy Protector</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <emdnDescription>TRACHEOSTOMY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB/300</reference>
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    <lastUpdated>2026-07-01T23:14:14.983Z</lastUpdated>
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    <deviceName>TraxGuard Tracheostomy Tube Holder</deviceName>
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    <reference>TH/100</reference>
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    <tradeName>Tracheostomy Tube Holder -Paediatric</tradeName>
    <deviceName>Tracheostomy Tube Holder -Paediatric</deviceName>
    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <reference>TH/150</reference>
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    <tradeName>Tracheostomy Tube Cleaning Swab Large</tradeName>
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    <manufacturerName>Insight Medical Products Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004395</manufacturerSrn>
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    <reference>TCS/900</reference>
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    <tradeName>Rota-Trach Inner Cannula Tracheostomy Tube</tradeName>
    <deviceName>Tracheostomy inner cannulas</deviceName>
    <manufacturerName>Vitaltec Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000011422</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5510700</reference>
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    <manufacturerName>Vitaltec Corporation</manufacturerName>
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    <reference>5410700</reference>
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    <tradeName>Rota-Trach Disposable Standard Tracheostomy Tube</tradeName>
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    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
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    <reference>5310700</reference>
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