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    <tradeName>ROMO SOFT</tradeName>
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    <reference>GS-2102</reference>
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    <lastUpdated>2026-07-03T19:04:22.746Z</lastUpdated>
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    <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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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <tradeName>BM Tracheostomy Tube with Evacuation Lumen</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <reference>225 50 00 2</reference>
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    <lastUpdated>2026-07-02T09:32:56.076Z</lastUpdated>
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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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    <deviceStatus>Piyasada</deviceStatus>
    <reference>222 30 00 2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:32:19.194Z</lastUpdated>
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    <udiDi>04711467491152</udiDi>
    <basicUdiDi>471146749TT02EB</basicUdiDi>
    <tradeName>Rota-Trach Disposable Standard Tracheostomy Tube</tradeName>
    <deviceName>Tracheostomy tubes, with cuff</deviceName>
    <manufacturerName>Vitaltec Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000011422</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</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>5310700</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:10:53.169Z</lastUpdated>
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    <udiDi>04250203225205</udiDi>
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    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Voice Cuff, Gr.9 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112436</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:20.664Z</lastUpdated>
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    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Suction Voice, Gr.7 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>112444</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:20.643Z</lastUpdated>
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    <tradeName>PercuTrach® PDT-Set Typ 1 + Optima PercuTrach® Suction Voice, Gr.9 mit atraumatischer Einführhilfe steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>112446</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:20.609Z</lastUpdated>
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    <udiDi>04250203225236</udiDi>
    <basicUdiDi>42502032PRI0804Y</basicUdiDi>
    <tradeName>Optima PercuTrach® Basic Cuff, Gr.7  mit atraumatischer Einführhilfe  steril, nicht MRT geeignet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102424</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:20.584Z</lastUpdated>
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  <row>
    <udiDi>04250203225243</udiDi>
    <basicUdiDi>42502032PRI0804Y</basicUdiDi>
    <tradeName>Optima PercuTrach® Basic Cuff, Gr.8  mit atraumatischer Einführhilfe  steril, nicht MRT geeignet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102425</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:20.560Z</lastUpdated>
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    <udiDi>04250203225250</udiDi>
    <basicUdiDi>42502032PRI0804Y</basicUdiDi>
    <tradeName>Optima PercuTrach® Basic Cuff, Gr.9  mit atraumatischer Einführhilfe  steril, nicht MRT geeignet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102426</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:57:20.532Z</lastUpdated>
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    <udiDi>04250203258739</udiDi>
    <basicUdiDi>42502032PRI0804Y</basicUdiDi>
    <tradeName>ProLine PercuTrach® Cuff, Gr.7  mit atraumatischer Einführhilfe  steril, nicht MRT geeignet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1021270</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:07.055Z</lastUpdated>
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    <udiDi>04250203258753</udiDi>
    <basicUdiDi>42502032PRI0804Y</basicUdiDi>
    <tradeName>ProLine PercuTrach® Cuff, Gr.8  mit atraumatischer Einführhilfe  steril, nicht MRT geeignet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1021280</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:07.009Z</lastUpdated>
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    <udiDi>04250203258777</udiDi>
    <basicUdiDi>42502032PRI0804Y</basicUdiDi>
    <tradeName>ProLine PercuTrach® Cuff, Gr.9  mit atraumatischer Einführhilfe  steril, nicht MRT geeignet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1021290</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:06.981Z</lastUpdated>
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    <basicUdiDi>42502032PRI0804Y</basicUdiDi>
    <tradeName>ProLine PercuTrach® Suction, Gr.7  mit atraumatischer Einführhilfe  steril, nicht MRT geeignet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1021370</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:06.962Z</lastUpdated>
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    <basicUdiDi>42502032PRI0804Y</basicUdiDi>
    <tradeName>ProLine PercuTrach® Suction, Gr.8  mit atraumatischer Einführhilfe  steril, nicht MRT geeignet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1021380</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:06.938Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1021390</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:06.918Z</lastUpdated>
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    <tradeName>ProLine PercuTrach® Cuff Voice, Gr.7  mit atraumatischer Einführhilfe  steril, nicht MRT geeignet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1021570</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:06.885Z</lastUpdated>
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    <tradeName>ProLine PercuTrach® Cuff Voice, Gr.8  mit atraumatischer Einführhilfe  steril, nicht MRT geeignet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1021580</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:06.860Z</lastUpdated>
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    <tradeName>ProLine PercuTrach® Cuff Voice, Gr.9  mit atraumatischer Einführhilfe  steril, nicht MRT geeignet</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1021590</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:56:06.835Z</lastUpdated>
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