<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00816349012709</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName>PTFE Guidewires (Vascular)</deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-114V</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:21:34.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013034</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-147V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013065</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-150V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013072</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-151V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013089</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-152V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013096</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-153V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013102</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-154V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013119</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-155V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013126</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-156V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013133</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-157V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:05.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013140</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-158V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013157</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-159V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013164</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-160V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013171</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-161V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013188</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-162V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013195</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-163V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013201</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-164V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013218</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-165V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013225</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-166V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349013232</udiDi>
    <basicUdiDi>081634901PTFEVASN2</basicUdiDi>
    <tradeName>Starter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020102</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCMBF-167V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:08:04.713Z</lastUpdated>
  </row>
</eudamedExport>