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    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></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>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-230-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:25.308Z</lastUpdated>
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    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></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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    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-231-06</reference>
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    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></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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    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-231-07</reference>
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    <udiDi>00841268109438</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></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>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-231-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:25.227Z</lastUpdated>
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    <udiDi>00841268109445</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></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>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-231-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:25.204Z</lastUpdated>
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    <udiDi>08809330389845</udiDi>
    <basicUdiDi>088093303RHVP0001U6</basicUdiDi>
    <tradeName>RHV-P (Y-connector)</tradeName>
    <deviceName>RHV Series [RHV-P (Y-connector)]</deviceName>
    <manufacturerName>HuBioMed Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000042815</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Not applicable</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:06:15.174Z</lastUpdated>
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    <udiDi>08809330388534</udiDi>
    <basicUdiDi>088093303RHVS0001V7</basicUdiDi>
    <tradeName>RHV-S (Y-connector)</tradeName>
    <deviceName>RHV Series [RHV-S (Y-connector)]</deviceName>
    <manufacturerName>HuBioMed Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000042815</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Not applicable</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:06:13.571Z</lastUpdated>
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    <udiDi>00763000713041</udiDi>
    <basicUdiDi>0763000B00008768P</basicUdiDi>
    <tradeName>N/A</tradeName>
    <deviceName>Adjustable Valve</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6248VAL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:07:56.643Z</lastUpdated>
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    <udiDi>D-898894V5</udiDi>
    <basicUdiDi>B-898894V5</basicUdiDi>
    <tradeName>D-898894V5</tradeName>
    <deviceName>VALVOLA EMOSTATICA Y(8F)CON PROL.cm 20 E RUB.3 VIE SMLL OFF 180�(43 psi)</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>898894</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:52:59.516Z</lastUpdated>
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    <udiDi>D-898889VC</udiDi>
    <basicUdiDi>B-898889VC</basicUdiDi>
    <tradeName>D-898889VC</tradeName>
    <deviceName>VALVOLA EMOSTATICA Y(8F)A SCATTO(60 psi)</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>898889</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:52:53.224Z</lastUpdated>
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    <udiDi>D-898798V8</udiDi>
    <basicUdiDi>B-898798V8</basicUdiDi>
    <tradeName>D-898798V8</tradeName>
    <deviceName>SET VALVOLA EMOSTATICA Y(9F)A VITE CON INTRODUTTORE PER GUIDA E TORQUER
  .014"-.021"(180 psi)</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>898798</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:52:39.448Z</lastUpdated>
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    <udiDi>D-898795V2</udiDi>
    <basicUdiDi>B-898795V2</basicUdiDi>
    <tradeName>D-898795V2</tradeName>
    <deviceName>VALVOLA A Y (9F) CON INTRODUTTORE E TORQUER PER GUIDA</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>898795</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:52:37.045Z</lastUpdated>
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    <udiDi>D-898754UL</udiDi>
    <basicUdiDi>B-898754UL</basicUdiDi>
    <tradeName>D-898754UL</tradeName>
    <deviceName>VALVOLA EMOSTATICA Y(9F)A VITE(180 psi)</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>898754</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:52:30.642Z</lastUpdated>
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    <udiDi>86989077509244</udiDi>
    <basicUdiDi>B-86989077509244</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Hemostasis Valve Set</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVSDK</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:23:06.573Z</lastUpdated>
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    <basicUdiDi>B-86989077509176</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Hemostasis Valve Set</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVSD50K</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:23:05.768Z</lastUpdated>
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    <basicUdiDi>B-86989077509008</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Hemostasis Valve Set</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVSD35K</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:23:04.969Z</lastUpdated>
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    <tradeName>ARES</tradeName>
    <deviceName>Hemostasis Valve Set</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVSD25K</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:23:00.969Z</lastUpdated>
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    <tradeName>ARES</tradeName>
    <deviceName>Hemostasis Valve Set</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVSPC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:18:45.736Z</lastUpdated>
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    <tradeName>ARES</tradeName>
    <deviceName>Hemostasis Valve Set</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVSD50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:18:44.152Z</lastUpdated>
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    <tradeName>ARES</tradeName>
    <deviceName>Hemostasis Valve Set</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVSD35</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:18:42.572Z</lastUpdated>
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