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    <manufacturerName>Beijing Demax Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005844</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <tradeName>Artix Thin-Walled Sheath, 90 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Inari Medical, Inc.</manufacturerName>
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    <tradeName>Artix Thin-Walled Sheath (65 cm)</tradeName>
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    <tradeName>ClotTriever</tradeName>
    <deviceName>ClotTriever Sheath, 13 Fr</deviceName>
    <manufacturerName>Inari Medical, Inc.</manufacturerName>
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    <basicUdiDi>085029100751-101ZC</basicUdiDi>
    <tradeName>ClotTriever Sheath</tradeName>
    <deviceName>ClotTriever Sheath, 16 Fr</deviceName>
    <manufacturerName>Inari Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008693</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>51-101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:46:32.751Z</lastUpdated>
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    <basicUdiDi>4035479BUDI00021PS</basicUdiDi>
    <tradeName>Selectra 3D-55-42</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOTRONIK SE &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>451790</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:28:27.263Z</lastUpdated>
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    <tradeName>Galt VTI® Introducer Kit</tradeName>
    <deviceName>Valved Tearaway Introducer Kit With Sideport</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-077-06</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:04:07.430Z</lastUpdated>
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    <basicUdiDi>08412681Galt-VTIR5</basicUdiDi>
    <tradeName>Galt VTI® Introducer Set</tradeName>
    <deviceName>Valved Tearaway Set Product Family</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <lastUpdated>2026-07-30T17:04:05.026Z</lastUpdated>
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    <basicUdiDi>08412681Micro-KITSG</basicUdiDi>
    <tradeName>Micro-Introducer Kit</tradeName>
    <deviceName>Micro Introducer Kits</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-002-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:04:00.221Z</lastUpdated>
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    <udiDi>00841268104471</udiDi>
    <basicUdiDi>08412681Tearaway-KITE7</basicUdiDi>
    <tradeName>Tearaway Introducer Kit</tradeName>
    <deviceName>Tearaway Introducer Kit</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>C0503</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT-009-03</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:58.620Z</lastUpdated>
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    <udiDi>00841268103177</udiDi>
    <basicUdiDi>08412681MA-CLI6Y</basicUdiDi>
    <tradeName>Micro-Access Elite HV Catheter Introducer Set with Hemostasis Valve</tradeName>
    <deviceName>Cath-Lab Introducer Kit Product Family</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-100-04</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:56.218Z</lastUpdated>
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    <udiDi>00841268101715</udiDi>
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    <tradeName>Tearaway Introducer Set</tradeName>
    <deviceName>Tearaway Product Family</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-105-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:38.570Z</lastUpdated>
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    <basicUdiDi>08412681MSTearaway-INT67</basicUdiDi>
    <tradeName>MicroSlide® Introducer Set</tradeName>
    <deviceName>Pediatric Tearaway Introducer Set</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-101-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:34.573Z</lastUpdated>
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    <basicUdiDi>08412681Galtstick-KITEH</basicUdiDi>
    <tradeName>GaltStick® Introducer Set</tradeName>
    <deviceName>Galtstick Introducer Kit</deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>C0501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>INT-036-06</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:03:33.765Z</lastUpdated>
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    <basicUdiDi>0827002CINC050-031_C1Y7</basicUdiDi>
    <tradeName>Flexor® Check-Flo®</tradeName>
    <deviceName>Flexor® Check-Flo® Introducer [Set, Raabe Modification,  Balkin Up &amp; Over® Contralateral Design]</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:01:07.220Z</lastUpdated>
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    <basicUdiDi>07050320000000000000012C8</basicUdiDi>
    <tradeName>RAIN Sheath™ Transradial Introducer</tradeName>
    <deviceName>Catheter Sheath Introducer - RAIN Sheath™ Transradial Introducer - Bare Mini Guidewire</deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000020031</manufacturerSrn>
    <authorisedRepresentativeName>Cordis Cashel</authorisedRepresentativeName>
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    <lastUpdated>2026-07-30T16:51:56.203Z</lastUpdated>
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    <tradeName>RAILWAY Sheathless Access System</tradeName>
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    <manufacturerName>Cordis US Corp.</manufacturerName>
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    <tradeName>RAILWAY Sheathless Access System</tradeName>
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    <manufacturerName>Cordis US Corp.</manufacturerName>
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    <deviceName>Catheter Sheath Introducer - AVANTI™+ Transradial Introducer Kit</deviceName>
    <manufacturerName>Cordis US Corp.</manufacturerName>
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    <tradeName>AVANTI™+ Catheter Sheath Introducer</tradeName>
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    <reference>402-604P</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:51:43.390Z</lastUpdated>
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