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    <tradeName>Tenzing 7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Route 92 Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007441</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:51.507Z</lastUpdated>
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    <udiDi>00853799007305</udiDi>
    <basicUdiDi>0853799007NRSEC</basicUdiDi>
    <tradeName>HiPoint 88 reperfusion catheter with Tenzing 8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Route 92 Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007441</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MANUAL CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2004-88-143R-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:51.489Z</lastUpdated>
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    <udiDi>00853799007428</udiDi>
    <basicUdiDi>0853799007NRSEC</basicUdiDi>
    <tradeName>HiPoint 70 reperfusion catheter with Tenzing 7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Route 92 Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007441</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MANUAL CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2004-70-142R-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:51.471Z</lastUpdated>
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    <udiDi>00853799007527</udiDi>
    <basicUdiDi>0853799007NSSEF</basicUdiDi>
    <tradeName>Base Camp Sheath System 90cm Berenstein</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Route 92 Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007441</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001-1-90B-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:51.451Z</lastUpdated>
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    <udiDi>00853799007565</udiDi>
    <basicUdiDi>0853799007NRSEC</basicUdiDi>
    <tradeName>FreeClimb 70 reperfusion catheter with Tenzing 7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Route 92 Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007441</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MANUAL CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7001-70-132R-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:51.432Z</lastUpdated>
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    <udiDi>00853799007589</udiDi>
    <basicUdiDi>0853799007NRSEC</basicUdiDi>
    <tradeName>FreeClimb 88 reperfusion catheter (x125cm) with Tenzing 8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Route 92 Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007441</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MANUAL CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7001-88-125R-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:51.418Z</lastUpdated>
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    <udiDi>00853799007602</udiDi>
    <basicUdiDi>0853799007NRSEC</basicUdiDi>
    <tradeName>FreeClimb 88 reperfusion catheter (x132cm) with Tenzing 8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Route 92 Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007441</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MANUAL CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7001-88-132R-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:51.405Z</lastUpdated>
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    <udiDi>00853799007862</udiDi>
    <basicUdiDi>0853799007NSSEF</basicUdiDi>
    <tradeName>8F Base Camp System Berenstein 80cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Route 92 Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007441</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001-2-80B-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:51.388Z</lastUpdated>
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    <udiDi>00853799007886</udiDi>
    <basicUdiDi>0853799007NSSEF</basicUdiDi>
    <tradeName>8F Base Camp System Berenstein 90cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Route 92 Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007441</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001-2-90B-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:51.368Z</lastUpdated>
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    <udiDi>00853799007817</udiDi>
    <basicUdiDi>0853799007NRSEC</basicUdiDi>
    <tradeName>FreeClimb 54 Reperfusion Catheter (x125cm) with Tenzing 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Route 92 Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007441</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0104010202</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7001-54-125R-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T04:11:49.668Z</lastUpdated>
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    <udiDi>00853799007800</udiDi>
    <basicUdiDi>0853799007NRSEC</basicUdiDi>
    <tradeName>FreeClimb 54 Reperfusion Catheter with Tenzing 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Route 92 Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007441</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010401020501</emdnCode>
    <emdnDescription>MANUAL CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7001-54-148R-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T04:11:46.797Z</lastUpdated>
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