<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08717853292866</udiDi>
    <basicUdiDi>B-08717853292866</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-153-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:38.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292859</udiDi>
    <basicUdiDi>B-08717853292859</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-123-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:37.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292842</udiDi>
    <basicUdiDi>B-08717853292842</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-103-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:36.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292835</udiDi>
    <basicUdiDi>B-08717853292835</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-083-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:30.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292828</udiDi>
    <basicUdiDi>B-08717853292828</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232-183-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:29.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292811</udiDi>
    <basicUdiDi>B-08717853292811</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232-153-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:27.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292804</udiDi>
    <basicUdiDi>B-08717853292804</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232-123-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:26.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292798</udiDi>
    <basicUdiDi>B-08717853292798</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232-103-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:20.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292781</udiDi>
    <basicUdiDi>B-08717853292781</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232-083-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:19.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292774</udiDi>
    <basicUdiDi>B-08717853292774</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230-183-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:18.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292767</udiDi>
    <basicUdiDi>B-08717853292767</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230-153-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:13.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292743</udiDi>
    <basicUdiDi>B-08717853292743</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230-103-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:11.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292736</udiDi>
    <basicUdiDi>B-08717853292736</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230-083-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:09.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292729</udiDi>
    <basicUdiDi>B-08717853292729</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-183-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:03.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292712</udiDi>
    <basicUdiDi>B-08717853292712</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-153-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:02.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292705</udiDi>
    <basicUdiDi>B-08717853292705</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-123-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:01.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292699</udiDi>
    <basicUdiDi>B-08717853292699</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-103-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:24:00.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292682</udiDi>
    <basicUdiDi>B-08717853292682</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227-083-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:23:54.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292675</udiDi>
    <basicUdiDi>B-08717853292675</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-183-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:23:53.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853292668</udiDi>
    <basicUdiDi>B-08717853292668</basicUdiDi>
    <tradeName>Sapphire NC</tradeName>
    <deviceName>Sapphire NC</deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225-153-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:23:51.886Z</lastUpdated>
  </row>
</eudamedExport>