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    <basicUdiDi>4987488AVF_HD_KR</basicUdiDi>
    <tradeName>A. V. Fistula Sets for Hemodialysis</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVFE1620CPLRG</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488098094</udiDi>
    <basicUdiDi>4987488AVF_HD_KR</basicUdiDi>
    <tradeName>A. V. Fistula Sets for Hemodialysis</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVFE1720CPLRG</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.711Z</lastUpdated>
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  <row>
    <udiDi>04987488103972</udiDi>
    <basicUdiDi>4987488AVF_F9</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>GR-6115E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488103989</udiDi>
    <basicUdiDi>4987488AVF_F9</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>GR-6116E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488103996</udiDi>
    <basicUdiDi>4987488AVF_F9</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>GR-6117E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488104009</udiDi>
    <basicUdiDi>4987488AVF_F9</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>GF-6115E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488104016</udiDi>
    <basicUdiDi>4987488AVF_F9</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>GF-6116E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488104023</udiDi>
    <basicUdiDi>4987488AVF_F9</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>GF-6117E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488104030</udiDi>
    <basicUdiDi>4987488AVF_PAINLESS_6Z</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set KAWASUMI PAINLESS NEEDLE</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>GF-65X5E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488104047</udiDi>
    <basicUdiDi>4987488AVF_PAINLESS_6Z</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set KAWASUMI PAINLESS NEEDLE</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>GF-65X6E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488104054</udiDi>
    <basicUdiDi>4987488AVF_F9</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-6115E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488104061</udiDi>
    <basicUdiDi>4987488AVF_PAINLESS_6Z</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set KAWASUMI PAINLESS NEEDLE</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-65X5E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987488104078</udiDi>
    <basicUdiDi>4987488AVF_PAINLESS_6Z</basicUdiDi>
    <tradeName>Arterial Venous Fistula Set KAWASUMI PAINLESS NEEDLE</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>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GF-65X6E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:58.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904399105099</udiDi>
    <basicUdiDi>89043991HSAVF01ZE</basicUdiDi>
    <tradeName>Arterial venous Fistula Needle Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Harsoria Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000018349</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0509</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:54:58.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904399105105</udiDi>
    <basicUdiDi>89043991HSAVF01ZE</basicUdiDi>
    <tradeName>Arterial venous Fistula Needle Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Harsoria Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000018349</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:54:58.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904399171087</udiDi>
    <basicUdiDi>89043991HSAVF01ZE</basicUdiDi>
    <tradeName>Arterial Venous Fistula Needle Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Harsoria Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000018349</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7108</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:54:35.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904399171094</udiDi>
    <basicUdiDi>89043991HSAVF01ZE</basicUdiDi>
    <tradeName>Arterial venous Fistula Needle Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Harsoria Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000018349</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7109</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:54:35.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904399171162</udiDi>
    <basicUdiDi>89043991HSAVF01ZE</basicUdiDi>
    <tradeName>Arterial venous Fistula Needle Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Harsoria Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000018349</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7116</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:54:35.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904399171179</udiDi>
    <basicUdiDi>89043991HSAVF01ZE</basicUdiDi>
    <tradeName>Arterial venous Fistula Needle Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Harsoria Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000018349</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7117</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:54:35.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>26939348193236</udiDi>
    <basicUdiDi>6939348121040072a010101BX</basicUdiDi>
    <tradeName>A.V.Fistula Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Xinjin Shifeng Medical Apparatus &amp; Instrument  Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016493</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X 17G x 25mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:24:01.205Z</lastUpdated>
  </row>
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