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    <tradeName>Welllead Tracheostomy Tube</tradeName>
    <deviceName>Tracheostomy Tube</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02A06303F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:52.763Z</lastUpdated>
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    <udiDi>06920687305547</udiDi>
    <basicUdiDi>69206873TT001QV</basicUdiDi>
    <tradeName>Tracheostomy Tubes</tradeName>
    <deviceName>Tracheostomy Tubes</deviceName>
    <manufacturerName>Tianjin Medis Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020126</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>TT-P1-30</reference>
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    <lastUpdated>2026-07-31T15:05:57.341Z</lastUpdated>
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    <udiDi>05901292107901</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>R0105010101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>33-3010</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:47:36.788Z</lastUpdated>
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    <udiDi>04250203221160</udiDi>
    <basicUdiDi>42502032PRI05959</basicUdiDi>
    <tradeName>PRIMEDISILK® T-Tubus, Gr. 8, steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200640</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:54:01.369Z</lastUpdated>
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  <row>
    <udiDi>04250203217675</udiDi>
    <basicUdiDi>42502032PRI0604S</basicUdiDi>
    <tradeName>PRIMEDIBUTTON®, Stoma Button Typ I, Gr. 6  Außendurchmesser: 9,5mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:48.642Z</lastUpdated>
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    <udiDi>04250203217552</udiDi>
    <basicUdiDi>42502032PRI0685A</basicUdiDi>
    <tradeName>PRIMEDISILK-VENT® Silikonkanüle, gesiebt Gr.8 Länge 62 mm mit 22 mm Anschluss + 1 Beutel a 5 Stck Primediair-Phon UltraFlow</tradeName>
    <deviceName>Primedisilk (Silikonkanülen)</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200624</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:34.895Z</lastUpdated>
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    <udiDi>04250203214681</udiDi>
    <basicUdiDi>42502032PRI0624W</basicUdiDi>
    <tradeName>Trachealkanüle Optima Basic Standard Gr.6, dehp-frei</tradeName>
    <deviceName>Optima, Ultrasoft, ProLine</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>R0105010101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>102013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:24.483Z</lastUpdated>
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    <udiDi>04250203214353</udiDi>
    <basicUdiDi>42502032PRI06656</basicUdiDi>
    <tradeName>Kinderkanüle NEO 3,0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
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    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:22.075Z</lastUpdated>
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    <udiDi>04250203212809</udiDi>
    <basicUdiDi>42502032PRI06758</basicUdiDi>
    <tradeName>Trachealkanüle SILVER, Standard Gr.3 Außenkanüle gesiebt, 1 Innenrohr gefenstert mit Sprechventil</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200913</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:18.081Z</lastUpdated>
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  <row>
    <udiDi>20884521175737</udiDi>
    <basicUdiDi>0763000B00005247M</basicUdiDi>
    <tradeName>20884521175737</tradeName>
    <deviceName>Shiley Cuffless DIC</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7UN80A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:02:17.702Z</lastUpdated>
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    <udiDi>20884521175751</udiDi>
    <basicUdiDi>0763000B00005247M</basicUdiDi>
    <tradeName>20884521175751</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9UN90A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:46:47.105Z</lastUpdated>
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    <udiDi>20884521175744</udiDi>
    <basicUdiDi>0763000B00005247M</basicUdiDi>
    <tradeName>20884521175744</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8UN85A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:46:47.057Z</lastUpdated>
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    <udiDi>10884521205499</udiDi>
    <basicUdiDi>0763000B000038987</basicUdiDi>
    <tradeName>10884521205499</tradeName>
    <deviceName>Shiley Cuffless RIC</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5UN70R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:48:42.439Z</lastUpdated>
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    <udiDi>10884521205543</udiDi>
    <basicUdiDi>0763000B000038987</basicUdiDi>
    <tradeName>10884521205543</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
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    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10UN10R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:40.226Z</lastUpdated>
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    <udiDi>10884521205536</udiDi>
    <basicUdiDi>0763000B000038987</basicUdiDi>
    <tradeName>10884521205536</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
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    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9UN90R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:40.153Z</lastUpdated>
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    <udiDi>10884521205529</udiDi>
    <basicUdiDi>0763000B000038987</basicUdiDi>
    <tradeName>10884521205529</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8UN85R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:40.098Z</lastUpdated>
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    <udiDi>10884521205512</udiDi>
    <basicUdiDi>0763000B000038987</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
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    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7UN80R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:39.953Z</lastUpdated>
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    <basicUdiDi>0763000B000038987</basicUdiDi>
    <tradeName>10884521205505</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
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    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
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    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6UN75R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:39.912Z</lastUpdated>
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    <udiDi>20884521175706</udiDi>
    <basicUdiDi>0763000B00005247M</basicUdiDi>
    <tradeName>20884521175706</tradeName>
    <deviceName>Shiley Cuffless DIC</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4UN65A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:57:21.637Z</lastUpdated>
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    <udiDi>10884521205482</udiDi>
    <basicUdiDi>0763000B000038987</basicUdiDi>
    <tradeName>10884521205482</tradeName>
    <deviceName>Shiley Cuffless RIC</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4UN65R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:56:35.141Z</lastUpdated>
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