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    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
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    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
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    <tradeName>SEAL™ Base</tradeName>
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    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
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    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0006-04E</reference>
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    <lastUpdated>2026-08-06T13:19:06.554Z</lastUpdated>
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    <basicUdiDi>0850052512SEALSV</basicUdiDi>
    <tradeName>SEAL™ Base</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035675</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
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    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0006-05E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-06T13:19:06.523Z</lastUpdated>
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    <tradeName>SEAL™ Base</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035675</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
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    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0006-06E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-06T13:19:06.499Z</lastUpdated>
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    <tradeName>SEAL™ Base</tradeName>
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    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035675</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0006-07E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-06T13:19:06.473Z</lastUpdated>
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    <basicUdiDi>0850052512SEALSV</basicUdiDi>
    <tradeName>SEAL™ ARC</tradeName>
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    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035675</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
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    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-08-06T13:19:06.434Z</lastUpdated>
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    <tradeName>SEAL™ ARC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035675</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0007-02E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-06T13:19:06.405Z</lastUpdated>
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    <basicUdiDi>0850052512SEALSV</basicUdiDi>
    <tradeName>SEAL™ ARC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035675</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000034988</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0007-03E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-06T13:19:06.382Z</lastUpdated>
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    <udiDi>00850052512262</udiDi>
    <basicUdiDi>0850052512SEALSV</basicUdiDi>
    <tradeName>SEAL™ ARC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035675</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
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    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0007-04E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-06T13:19:06.361Z</lastUpdated>
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    <basicUdiDi>0850052512SEALSV</basicUdiDi>
    <tradeName>SEAL™ ARC</tradeName>
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    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035675</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
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    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0007-05E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-06T13:19:06.337Z</lastUpdated>
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    <basicUdiDi>0850052512SEALSV</basicUdiDi>
    <tradeName>SEAL™ ARC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035675</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
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    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0007-06E</reference>
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    <lastUpdated>2026-08-06T13:19:06.311Z</lastUpdated>
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    <basicUdiDi>0850052512SEALSV</basicUdiDi>
    <tradeName>SEAL™ ARC</tradeName>
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    <manufacturerName>Galaxy Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000035675</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
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    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0007-07E</reference>
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    <lastUpdated>2026-08-06T13:19:06.243Z</lastUpdated>
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