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    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDICOMB®, Gr.8, L = 70 mm</tradeName>
    <deviceName>Primedistom</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>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200730</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:54:00.571Z</lastUpdated>
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    <udiDi>04250203220453</udiDi>
    <basicUdiDi>42502032PRI08254</basicUdiDi>
    <tradeName>PercuTrach® PDT-Set Typ 2 + Optima Basic Cuff, Gr.7 steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000036373</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>112324</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:59.763Z</lastUpdated>
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    <udiDi>04250203220361</udiDi>
    <basicUdiDi>42502032PRI0804Y</basicUdiDi>
    <tradeName>Optima PercuTrach® Voice 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>MDR 2017/745</legislation>
    <emdnCode>R0105020101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102434</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:58.969Z</lastUpdated>
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    <udiDi>04250203220347</udiDi>
    <basicUdiDi>42502032PRI0384Z</basicUdiDi>
    <tradeName>PercuTrach Dilatationsset II  mit Spreizzange  steril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010603</emdnCode>
    <emdnDescription>GRIGGS TRACHEOSTOMY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102087</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:54.973Z</lastUpdated>
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  <row>
    <udiDi>04250203220262</udiDi>
    <basicUdiDi>42502032PRI0274U</basicUdiDi>
    <tradeName>Filterkassette 15/22 mm für PRIMEDI-PHON PLUS® unsteril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200351</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:52.549Z</lastUpdated>
  </row>
  <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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  <row>
    <udiDi>04250203217453</udiDi>
    <basicUdiDi>42502032PRI0695C</basicUdiDi>
    <tradeName>Priflex® Trachealkanüle, drahtverstärkt-flexibel, gesiebt, Gr.7</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>R0105010202</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200809</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:33.292Z</lastUpdated>
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  <row>
    <udiDi>04250203217408</udiDi>
    <basicUdiDi>42502032PRI07353</basicUdiDi>
    <tradeName>22 mm-Silikonadapter, à 4 Stück verpackt unsteril</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200828</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:32.485Z</lastUpdated>
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    <udiDi>04250203215213</udiDi>
    <basicUdiDi>42502032PRI0094S</basicUdiDi>
    <tradeName>Duschschutz</tradeName>
    <deviceName>Duschschutz</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:28.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250203215060</udiDi>
    <basicUdiDi>42502032PRI0634Y</basicUdiDi>
    <tradeName>Ersatzinnenkanüle Optima/Ultrasoft Gr.6 transparent dehp-frei, steril</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>R010503</emdnCode>
    <emdnDescription>TRACHEOSTOMY INNER CANNULAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:26.878Z</lastUpdated>
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  <row>
    <udiDi>04250203215053</udiDi>
    <basicUdiDi>42502032PRI0084Q</basicUdiDi>
    <tradeName>Dekanülierungsstopfen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102082</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:26.076Z</lastUpdated>
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  <row>
    <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>
    <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>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>
    <legislation>MDR 2017/745</legislation>
    <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>04250203214230</udiDi>
    <basicUdiDi>42502032PRI0264S</basicUdiDi>
    <tradeName>PRIMEDI-PHON PLUS® (transparent, O2-Anschluss) Sprechventil für Tracheotomierte,</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200355</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:20.477Z</lastUpdated>
  </row>
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    <udiDi>04250203214018</udiDi>
    <basicUdiDi>42502032PRI0254Q</basicUdiDi>
    <tradeName>PRIMEDI-PHON Sprechventil für Tracheotomierte,</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R90060202</emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200358</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:19.683Z</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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    <udiDi>04250203212335</udiDi>
    <basicUdiDi>42502032PRI0054J</basicUdiDi>
    <tradeName>PRIMEDISTRIP® BASIC RUND</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R01058099</emdnCode>
    <emdnDescription>TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200360</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:13.289Z</lastUpdated>
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    <udiDi>04250203210683</udiDi>
    <basicUdiDi>42502032PRI0224J</basicUdiDi>
    <tradeName>PRIMEDIAIR ® -KAN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R040201</emdnCode>
    <emdnDescription>TRACHEOSTOMY HUMIDIFIERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20485</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:11.740Z</lastUpdated>
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    <udiDi>04250203207478</udiDi>
    <basicUdiDi>42502032PRI0614U</basicUdiDi>
    <tradeName>PRIMEDISILK® Tracheo-Safe L= 70 mm, steril</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>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20898</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:53:05.262Z</lastUpdated>
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