<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08717853297670</udiDi>
    <basicUdiDi>B-08717853297670</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-382-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:29:08.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297663</udiDi>
    <basicUdiDi>B-08717853297663</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-332-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:29:07.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297656</udiDi>
    <basicUdiDi>B-08717853297656</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-282-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:29:00.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297649</udiDi>
    <basicUdiDi>B-08717853297649</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-232-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:59.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297632</udiDi>
    <basicUdiDi>B-08717853297632</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-182-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:58.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297625</udiDi>
    <basicUdiDi>B-08717853297625</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-152-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:56.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297618</udiDi>
    <basicUdiDi>B-08717853297618</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-132-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:50.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297601</udiDi>
    <basicUdiDi>B-08717853297601</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240-092-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:49.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297595</udiDi>
    <basicUdiDi>B-08717853297595</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Pus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-382-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:47.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297588</udiDi>
    <basicUdiDi>B-08717853297588</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-332-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:46.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297571</udiDi>
    <basicUdiDi>B-08717853297571</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-282-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:40.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297564</udiDi>
    <basicUdiDi>B-08717853297564</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-232-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:38.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297557</udiDi>
    <basicUdiDi>B-08717853297557</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-182-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:37.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297540</udiDi>
    <basicUdiDi>B-08717853297540</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-152-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:36.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297533</udiDi>
    <basicUdiDi>B-08717853297533</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-132-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:29.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297526</udiDi>
    <basicUdiDi>B-08717853297526</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-092-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:28.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297519</udiDi>
    <basicUdiDi>B-08717853297519</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230-382-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:26.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297502</udiDi>
    <basicUdiDi>B-08717853297502</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230-332-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:25.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297496</udiDi>
    <basicUdiDi>B-08717853297496</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230-282-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:19.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853297489</udiDi>
    <basicUdiDi>B-08717853297489</basicUdiDi>
    <tradeName>Combo Plus</tradeName>
    <deviceName>Combo Plus Dual Therapy Stent</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0704020102</emdnCode>
    <emdnDescription>COATED CORONARY STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230-232-11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:28:18.459Z</lastUpdated>
  </row>
</eudamedExport>