<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987488869120</udiDi>
    <basicUdiDi>B-04987488869120</basicUdiDi>
    <tradeName>04987488869120</tradeName>
    <deviceName>A. V. Fistula Sets  GF-6205E</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-6205E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:58.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488869113</udiDi>
    <basicUdiDi>B-04987488869113</basicUdiDi>
    <tradeName>04987488869113</tradeName>
    <deviceName>A. V. Fistula Sets  GF-6204E</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-6204E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:56.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488042356</udiDi>
    <basicUdiDi>B-04987488042356</basicUdiDi>
    <tradeName>04987488042356</tradeName>
    <deviceName>A. V. Fistula Sets  GF-6127EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-6127EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:28.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488046446</udiDi>
    <basicUdiDi>B-04987488046446</basicUdiDi>
    <tradeName>04987488046446</tradeName>
    <deviceName>A. V. Fistula Sets  GR-6316E</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-6316E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:26.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488042523</udiDi>
    <basicUdiDi>B-04987488042523</basicUdiDi>
    <tradeName>04987488042523</tradeName>
    <deviceName>A. V. Fistula Sets  GF-6126EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-6126EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:25.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488001704</udiDi>
    <basicUdiDi>B-04987488001704</basicUdiDi>
    <tradeName>04987488001704</tradeName>
    <deviceName>A. V. Fistula Sets  GR-2238EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-2238EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:07.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488001698</udiDi>
    <basicUdiDi>B-04987488001698</basicUdiDi>
    <tradeName>04987488001698</tradeName>
    <deviceName>A. V. Fistula Sets  GR-2237EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-2237EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:07.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488001681</udiDi>
    <basicUdiDi>B-04987488001681</basicUdiDi>
    <tradeName>04987488001681</tradeName>
    <deviceName>A. V. Fistula Sets  GR-2234EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-2234EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:06.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488001674</udiDi>
    <basicUdiDi>B-04987488001674</basicUdiDi>
    <tradeName>04987488001674</tradeName>
    <deviceName>A. V. Fistula Sets  GR-1338EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-1338EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:02.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488001667</udiDi>
    <basicUdiDi>B-04987488001667</basicUdiDi>
    <tradeName>04987488001667</tradeName>
    <deviceName>A. V. Fistula Sets  GR-1334EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-1334EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:01.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488001292</udiDi>
    <basicUdiDi>B-04987488001292</basicUdiDi>
    <tradeName>04987488001292</tradeName>
    <deviceName>A. V. Fistula Sets  GR-2236EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-2236EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:28:00.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488001285</udiDi>
    <basicUdiDi>B-04987488001285</basicUdiDi>
    <tradeName>04987488001285</tradeName>
    <deviceName>A. V. Fistula Sets  GR-2235EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-2235EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:27:59.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488001278</udiDi>
    <basicUdiDi>B-04987488001278</basicUdiDi>
    <tradeName>04987488001278</tradeName>
    <deviceName>A. V. Fistula Sets  GR-1337EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-1337EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:27:55.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488001193</udiDi>
    <basicUdiDi>B-04987488001193</basicUdiDi>
    <tradeName>04987488001193</tradeName>
    <deviceName>A. V. Fistula Sets  GR-1336EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-1336EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:27:55.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488001186</udiDi>
    <basicUdiDi>B-04987488001186</basicUdiDi>
    <tradeName>04987488001186</tradeName>
    <deviceName>A. V. Fistula Sets  GR-1335EMG</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-1335EMG</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:27:54.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488000851</udiDi>
    <basicUdiDi>B-04987488000851</basicUdiDi>
    <tradeName>04987488000851</tradeName>
    <deviceName>A. V. Fistula Sets  GF-2426S0E</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>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-2426S0E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:27:53.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987350743404</udiDi>
    <basicUdiDi>B-04987350743404</basicUdiDi>
    <tradeName>TERUMO DENTAL NEEDLE</tradeName>
    <deviceName>TERUMO DENTAL NEEDLE</deviceName>
    <manufacturerName>AIR WATER REALIZE INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000029803</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010601</emdnCode>
    <emdnDescription>CARPULE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DN*M3021G</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:27:49.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987350743381</udiDi>
    <basicUdiDi>B-04987350743381</basicUdiDi>
    <tradeName>TERUMO DENTAL NEEDLE</tradeName>
    <deviceName>TERUMO DENTAL NEEDLE</deviceName>
    <manufacturerName>AIR WATER REALIZE INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000029803</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010601</emdnCode>
    <emdnDescription>CARPULE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DN*M3021F</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:27:48.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987350743367</udiDi>
    <basicUdiDi>B-04987350743367</basicUdiDi>
    <tradeName>TERUMO DENTAL NEEDLE</tradeName>
    <deviceName>TERUMO DENTAL NEEDLE</deviceName>
    <manufacturerName>AIR WATER REALIZE INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000029803</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010601</emdnCode>
    <emdnDescription>CARPULE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DN*M3021B</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:27:47.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987350743343</udiDi>
    <basicUdiDi>B-04987350743343</basicUdiDi>
    <tradeName>TERUMO DENTAL NEEDLE</tradeName>
    <deviceName>TERUMO DENTAL NEEDLE</deviceName>
    <manufacturerName>AIR WATER REALIZE INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000029803</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010601</emdnCode>
    <emdnDescription>CARPULE NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DN*M3016F</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:27:47.097Z</lastUpdated>
  </row>
</eudamedExport>