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    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <reference>GF-6218EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.381Z</lastUpdated>
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    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
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    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.336Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
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    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-6226EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.318Z</lastUpdated>
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    <basicUdiDi>B-04987488871901</basicUdiDi>
    <tradeName>04987488871901</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-6227EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.301Z</lastUpdated>
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    <basicUdiDi>B-04987488871918</basicUdiDi>
    <tradeName>04987488871918</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-6228EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.285Z</lastUpdated>
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    <udiDi>04987488871925</udiDi>
    <basicUdiDi>B-04987488871925</basicUdiDi>
    <tradeName>04987488871925</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2204EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.265Z</lastUpdated>
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    <udiDi>04987488871932</udiDi>
    <basicUdiDi>B-04987488871932</basicUdiDi>
    <tradeName>04987488871932</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2205EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.240Z</lastUpdated>
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    <udiDi>04987488871949</udiDi>
    <basicUdiDi>B-04987488871949</basicUdiDi>
    <tradeName>04987488871949</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2206EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.222Z</lastUpdated>
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    <udiDi>04987488871963</udiDi>
    <basicUdiDi>B-04987488871963</basicUdiDi>
    <tradeName>04987488871963</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2208EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.181Z</lastUpdated>
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    <udiDi>04987488871970</udiDi>
    <basicUdiDi>B-04987488871970</basicUdiDi>
    <tradeName>04987488871970</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2214EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.158Z</lastUpdated>
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    <udiDi>04987488871987</udiDi>
    <basicUdiDi>B-04987488871987</basicUdiDi>
    <tradeName>04987488871987</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2215EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.131Z</lastUpdated>
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    <udiDi>04987488871994</udiDi>
    <basicUdiDi>B-04987488871994</basicUdiDi>
    <tradeName>04987488871994</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2216EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.104Z</lastUpdated>
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    <udiDi>04987488872007</udiDi>
    <basicUdiDi>B-04987488872007</basicUdiDi>
    <tradeName>04987488872007</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2217EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.076Z</lastUpdated>
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    <udiDi>04987488872014</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2218EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.052Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
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    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2224EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.031Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2225EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:56.014Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2226EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:55.989Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000011253</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2227EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:55.969Z</lastUpdated>
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    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
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    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2228EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:55.949Z</lastUpdated>
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