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    <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>GR-5308E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.503Z</lastUpdated>
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    <basicUdiDi>B-04987488874070</basicUdiDi>
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    <manufacturerName>SB-KAWASUMI LABORATORIES, INC.</manufacturerName>
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    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-5314E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.485Z</lastUpdated>
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    <basicUdiDi>B-04987488874087</basicUdiDi>
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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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-5315E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.469Z</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>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-5316E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.453Z</lastUpdated>
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    <udiDi>04987488874100</udiDi>
    <basicUdiDi>B-04987488874100</basicUdiDi>
    <tradeName>04987488874100</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>GR-5317E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.439Z</lastUpdated>
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    <udiDi>04987488874117</udiDi>
    <basicUdiDi>B-04987488874117</basicUdiDi>
    <tradeName>04987488874117</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>GR-5318E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.423Z</lastUpdated>
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    <udiDi>04987488874124</udiDi>
    <basicUdiDi>B-04987488874124</basicUdiDi>
    <tradeName>04987488874124</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>GR-5324E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.402Z</lastUpdated>
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    <udiDi>04987488874131</udiDi>
    <basicUdiDi>B-04987488874131</basicUdiDi>
    <tradeName>04987488874131</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>GR-5325E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.386Z</lastUpdated>
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    <udiDi>04987488874148</udiDi>
    <basicUdiDi>B-04987488874148</basicUdiDi>
    <tradeName>04987488874148</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>GR-5326E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.365Z</lastUpdated>
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    <udiDi>04987488874155</udiDi>
    <basicUdiDi>B-04987488874155</basicUdiDi>
    <tradeName>04987488874155</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>GR-5327E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.343Z</lastUpdated>
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    <udiDi>04987488874162</udiDi>
    <basicUdiDi>B-04987488874162</basicUdiDi>
    <tradeName>04987488874162</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>GR-5328E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.323Z</lastUpdated>
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    <udiDi>04987488874179</udiDi>
    <basicUdiDi>B-04987488874179</basicUdiDi>
    <tradeName>04987488874179</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>GR-1324E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.303Z</lastUpdated>
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    <udiDi>04987488874186</udiDi>
    <basicUdiDi>B-04987488874186</basicUdiDi>
    <tradeName>04987488874186</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>GR-1325E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.289Z</lastUpdated>
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    <udiDi>04987488874193</udiDi>
    <basicUdiDi>B-04987488874193</basicUdiDi>
    <tradeName>04987488874193</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>GR-1326E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.268Z</lastUpdated>
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    <udiDi>04987488874209</udiDi>
    <basicUdiDi>B-04987488874209</basicUdiDi>
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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>GR-1327E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.249Z</lastUpdated>
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    <udiDi>04987488874216</udiDi>
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    <tradeName>04987488874216</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>GR-1328E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.228Z</lastUpdated>
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    <udiDi>04987488874421</udiDi>
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    <tradeName>04987488874421</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>GR-6204EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.211Z</lastUpdated>
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    <udiDi>04987488874438</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>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-6205EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.195Z</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>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-6206EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.176Z</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>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-6207EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:41.156Z</lastUpdated>
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