<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800017600635</udiDi>
    <basicUdiDi>B-08800017600635</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSVP-8T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:35.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600628</udiDi>
    <basicUdiDi>B-08800017600628</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSVP-8B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:34.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600611</udiDi>
    <basicUdiDi>B-08800017600611</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSVP-8A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:33.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600581</udiDi>
    <basicUdiDi>B-08800017600581</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSMVP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:29.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600574</udiDi>
    <basicUdiDi>B-08800017600574</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSMP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:28.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600604</udiDi>
    <basicUdiDi>B-08800017600604</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSVP-13A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:27.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600598</udiDi>
    <basicUdiDi>B-08800017600598</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSVP-11A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:27.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600567</udiDi>
    <basicUdiDi>B-08800017600567</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSS20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:10.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600550</udiDi>
    <basicUdiDi>B-08800017600550</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSS15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:09.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600543</udiDi>
    <basicUdiDi>B-08800017600543</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSS10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:08.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600536</udiDi>
    <basicUdiDi>B-08800017600536</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSM20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:07.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600529</udiDi>
    <basicUdiDi>B-08800017600529</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSM15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:03.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800017600512</udiDi>
    <basicUdiDi>B-08800017600512</basicUdiDi>
    <tradeName>LIBRA</tradeName>
    <deviceName>LIBRA</deviceName>
    <manufacturerName>Woosung Medi-Filtech</manufacturerName>
    <manufacturerSrn>KR-MF-000004529</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSM10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:00:03.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034468097</udiDi>
    <basicUdiDi>B-07798034468097</basicUdiDi>
    <tradeName>Subiton CIFO</tradeName>
    <deviceName>Sistema estéril de cifoplastía por balón – Componentes del set</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>885008</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:06.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034468080</udiDi>
    <basicUdiDi>B-07798034468080</basicUdiDi>
    <tradeName>Subiton CIFO</tradeName>
    <deviceName>Sistema estéril de cifoplastía por balón – Componentes del set</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>885007</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:05.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034468073</udiDi>
    <basicUdiDi>B-07798034468073</basicUdiDi>
    <tradeName>Subiton CIFO</tradeName>
    <deviceName>Sistema estéril de cifoplastía por balón – Componentes del set</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>885006</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:10:04.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034468035</udiDi>
    <basicUdiDi>B-07798034468035</basicUdiDi>
    <tradeName>Subiton CIFO</tradeName>
    <deviceName>Sistema estéril de cifoplastía por balón – Componentes del set</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>885003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:58.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034468042</udiDi>
    <basicUdiDi>B-07798034468042</basicUdiDi>
    <tradeName>Subiton CIFO</tradeName>
    <deviceName>Sistema estéril de cifoplastía por balón – Componentes del set</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>885005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:58.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034468028</udiDi>
    <basicUdiDi>B-07798034468028</basicUdiDi>
    <tradeName>Subiton CIFO</tradeName>
    <deviceName>Sistema estéril de cifoplastía por balón – Componentes del set</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>885002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:57.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034468011</udiDi>
    <basicUdiDi>B-07798034468011</basicUdiDi>
    <tradeName>Subiton CIFO</tradeName>
    <deviceName>Sistema estéril de cifoplastía por balón – Componentes del set</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>885001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:53.375Z</lastUpdated>
  </row>
</eudamedExport>