<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987488874865</udiDi>
    <basicUdiDi>B-04987488874865</basicUdiDi>
    <tradeName>04987488874865</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-5328EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874872</udiDi>
    <basicUdiDi>B-04987488874872</basicUdiDi>
    <tradeName>04987488874872</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-1304EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874889</udiDi>
    <basicUdiDi>B-04987488874889</basicUdiDi>
    <tradeName>04987488874889</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-1305EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874896</udiDi>
    <basicUdiDi>B-04987488874896</basicUdiDi>
    <tradeName>04987488874896</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-1306EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874902</udiDi>
    <basicUdiDi>B-04987488874902</basicUdiDi>
    <tradeName>04987488874902</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-1307EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874919</udiDi>
    <basicUdiDi>B-04987488874919</basicUdiDi>
    <tradeName>04987488874919</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-1308EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874926</udiDi>
    <basicUdiDi>B-04987488874926</basicUdiDi>
    <tradeName>04987488874926</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-1314EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874933</udiDi>
    <basicUdiDi>B-04987488874933</basicUdiDi>
    <tradeName>04987488874933</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-1315EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874940</udiDi>
    <basicUdiDi>B-04987488874940</basicUdiDi>
    <tradeName>04987488874940</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-1316EMG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874957</udiDi>
    <basicUdiDi>B-04987488874957</basicUdiDi>
    <tradeName>04987488874957</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-1317EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874964</udiDi>
    <basicUdiDi>B-04987488874964</basicUdiDi>
    <tradeName>04987488874964</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-1318EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874971</udiDi>
    <basicUdiDi>B-04987488874971</basicUdiDi>
    <tradeName>04987488874971</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-1324EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874988</udiDi>
    <basicUdiDi>B-04987488874988</basicUdiDi>
    <tradeName>04987488874988</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-1325EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488874995</udiDi>
    <basicUdiDi>B-04987488874995</basicUdiDi>
    <tradeName>04987488874995</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-1326EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488875558</udiDi>
    <basicUdiDi>B-04987488875558</basicUdiDi>
    <tradeName>04987488875558</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-1327EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488875565</udiDi>
    <basicUdiDi>B-04987488875565</basicUdiDi>
    <tradeName>04987488875565</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-1328EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488875572</udiDi>
    <basicUdiDi>B-04987488875572</basicUdiDi>
    <tradeName>04987488875572</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-2414S0E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488875589</udiDi>
    <basicUdiDi>B-04987488875589</basicUdiDi>
    <tradeName>04987488875589</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-2415S0E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488875596</udiDi>
    <basicUdiDi>B-04987488875596</basicUdiDi>
    <tradeName>04987488875596</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-2416S0E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488875602</udiDi>
    <basicUdiDi>B-04987488875602</basicUdiDi>
    <tradeName>04987488875602</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-2417S0E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:40.152Z</lastUpdated>
  </row>
</eudamedExport>