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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <udiDi>07798034468004</udiDi>
    <basicUdiDi>B-07798034468004</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>885000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:52.455Z</lastUpdated>
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    <udiDi>07798034466741</udiDi>
    <basicUdiDi>B-07798034466741</basicUdiDi>
    <tradeName>Set Subiton CIFO</tradeName>
    <deviceName>Sistema estéril de cifoplastía por balón</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>880674</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:23.816Z</lastUpdated>
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    <udiDi>07798034466734</udiDi>
    <basicUdiDi>B-07798034466734</basicUdiDi>
    <tradeName>Set Subiton CIFO</tradeName>
    <deviceName>Sistema estéril de cifoplastía por balón</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>880673</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:23.034Z</lastUpdated>
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    <basicUdiDi>B-07798034466727</basicUdiDi>
    <tradeName>Set Subiton CIFO</tradeName>
    <deviceName>Sistema estéril de cifoplastía por balón</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
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    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880672</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:22.217Z</lastUpdated>
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    <basicUdiDi>B-07798034464952</basicUdiDi>
    <tradeName>Subiton VTP</tradeName>
    <deviceName>Aguja de punción de cuerpo vertebral</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
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    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880495</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:21.417Z</lastUpdated>
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    <tradeName>Subiton VTP</tradeName>
    <deviceName>Aguja de punción de cuerpo vertebral</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880491</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:17.531Z</lastUpdated>
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    <basicUdiDi>B-07798034464907</basicUdiDi>
    <tradeName>Subiton VTP</tradeName>
    <deviceName>Aguja de punción de cuerpo vertebral</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880490</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:16.625Z</lastUpdated>
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    <basicUdiDi>B-07798034464846</basicUdiDi>
    <tradeName>Set Subiton VTP</tradeName>
    <deviceName>Sistema estéril de aplicación de cemento para vertebroplastía</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
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    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880484</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:15.811Z</lastUpdated>
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    <tradeName>Set Subiton VTP</tradeName>
    <deviceName>Sistema estéril de aplicación de cemento para vertebroplastía</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
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    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880481</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <tradeName>Set Subiton VTP INTEGRAL</tradeName>
    <deviceName>Sistema estéril de aplicación de cemento para vertebroplastía</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880478</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:09:11.030Z</lastUpdated>
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