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    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SWVP-13T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:53.842Z</lastUpdated>
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    <udiDi>08809272564805</udiDi>
    <basicUdiDi>B-08809272564805</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:53.049Z</lastUpdated>
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    <udiDi>08809272564799</udiDi>
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    <tradeName>SPASY</tradeName>
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    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWVP-8B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:52.242Z</lastUpdated>
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    <udiDi>08809272564782</udiDi>
    <basicUdiDi>B-08809272564782</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWVP-8S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:48.456Z</lastUpdated>
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    <udiDi>08809272564775</udiDi>
    <basicUdiDi>B-08809272564775</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SWVP-8A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:48.314Z</lastUpdated>
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    <udiDi>08809272564768</udiDi>
    <basicUdiDi>B-08809272564768</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS6601-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:46.955Z</lastUpdated>
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    <udiDi>08809272564751</udiDi>
    <basicUdiDi>B-08809272564751</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>CS6601-06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:45.831Z</lastUpdated>
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    <udiDi>08809272564720</udiDi>
    <basicUdiDi>B-08809272564720</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>CS6601-05-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:41.927Z</lastUpdated>
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    <udiDi>08809272564744</udiDi>
    <basicUdiDi>B-08809272564744</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>CS6601-05-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:40.233Z</lastUpdated>
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    <udiDi>08809272564737</udiDi>
    <basicUdiDi>B-08809272564737</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>CS6601-05-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:39.564Z</lastUpdated>
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    <udiDi>08809272564713</udiDi>
    <basicUdiDi>B-08809272564713</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SWM20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:24.163Z</lastUpdated>
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    <udiDi>08809272564706</udiDi>
    <basicUdiDi>B-08809272564706</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SWM15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:22.567Z</lastUpdated>
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    <udiDi>08809272564690</udiDi>
    <basicUdiDi>B-08809272564690</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SWM10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:21.763Z</lastUpdated>
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    <udiDi>08809272564362</udiDi>
    <basicUdiDi>B-08809272564362</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>JMPP0130BF</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:16:17.860Z</lastUpdated>
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    <udiDi>08809272563839</udiDi>
    <basicUdiDi>B-08809272563839</basicUdiDi>
    <tradeName>Blue Pecker Plus</tradeName>
    <deviceName>Blue Pecker Plus</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SWVP-13H11A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:15:45.733Z</lastUpdated>
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    <udiDi>08809272563327</udiDi>
    <basicUdiDi>B-08809272563327</basicUdiDi>
    <tradeName>08809272563327</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SWVP-11A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:14:50.444Z</lastUpdated>
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    <udiDi>08809272563310</udiDi>
    <basicUdiDi>B-08809272563310</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SWVP-13A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:14:46.445Z</lastUpdated>
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    <udiDi>08809272562924</udiDi>
    <basicUdiDi>B-08809272562924</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</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>JMSWBS-9B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:14:14.356Z</lastUpdated>
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    <udiDi>08809272562900</udiDi>
    <basicUdiDi>B-08809272562900</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SWVP-8T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:14:12.765Z</lastUpdated>
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    <udiDi>08809272562870</udiDi>
    <basicUdiDi>B-08809272562870</basicUdiDi>
    <tradeName>SPASY</tradeName>
    <deviceName>SPASY</deviceName>
    <manufacturerName>Seawon Meditech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007442</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>SWBS-9B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:14:11.953Z</lastUpdated>
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