<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00853799007251</udiDi>
    <basicUdiDi>08537990076001VF</basicUdiDi>
    <tradeName>Tenzing 7</tradeName>
    <deviceName>Tenzing 7 Delivery Catheter</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>MDR 2017/745</legislation>
    <emdnCode>C0104010202</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:39:35.856Z</lastUpdated>
  </row>
</eudamedExport>