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    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HDA(a1-b2-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.639Z</lastUpdated>
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    <udiDi>06937909348015</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HDB(a1-b2-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HDB(a1-b2-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.627Z</lastUpdated>
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    <udiDi>06937909348022</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HSA(a1-b2-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HSA(a1-b2-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.604Z</lastUpdated>
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    <udiDi>06937909348039</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HSB(a1-b2-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HSB(a1-b2-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.589Z</lastUpdated>
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    <udiDi>06937909348046</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HSC(a1-b2-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HSC(a1-b2-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.575Z</lastUpdated>
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    <udiDi>06937909358007</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HDA(b1-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HDA(b1-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.560Z</lastUpdated>
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    <udiDi>06937909358014</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HDB(b1-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HDB(b1-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.542Z</lastUpdated>
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    <udiDi>06937909358021</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HSA(b1-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HSA(b1-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.526Z</lastUpdated>
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  <row>
    <udiDi>06937909358038</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HSB(b1-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HSB(b1-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.512Z</lastUpdated>
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    <udiDi>06937909358045</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HSC(b1-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HSC(b1-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.491Z</lastUpdated>
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  <row>
    <udiDi>06937909368006</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HDA(a1-b1-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HDA(a1-b1-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.478Z</lastUpdated>
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  <row>
    <udiDi>06937909368013</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HDB(a1-b1-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HDB(a1-b1-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.463Z</lastUpdated>
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  <row>
    <udiDi>06937909368020</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HSA(a1-b1-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HSA(a1-b1-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:53.442Z</lastUpdated>
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    <udiDi>06937909368037</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HSB(a1-b1-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HSB(a1-b1-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:33.318Z</lastUpdated>
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  <row>
    <udiDi>06937909368044</udiDi>
    <basicUdiDi>69379093HBTS003YF</basicUdiDi>
    <tradeName>OCI-BL-HSC(a1-b1-c1-d1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CHENGDU OCI MEDICAL DEVICES CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009700</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>F020199</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCI-BL-HSC(a1-b1-c1-d1)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:33.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056992333383</udiDi>
    <basicUdiDi>803377232HMF-ETO-LD</basicUdiDi>
    <tradeName>HF-400 RENAFLO HEMOFILTER</tradeName>
    <deviceName>HEMOFILTRATION DEVICES</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F010604</emdnCode>
    <emdnDescription>DIALYSERS FOR SPECIAL HAEMODIAFILTRATION AND OTHER THERAPIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93024-130</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:51:44.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>04806538160805</udiDi>
    <basicUdiDi>480653816001CK</basicUdiDi>
    <tradeName>BIONIC FISTULA NEEDLE</tradeName>
    <deviceName>A.V. FISTULA NEEDLE SET</deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012049</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>840-VGAM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:46:32.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>03661379281901</udiDi>
    <basicUdiDi>3661379ASS13DIA2AG9</basicUdiDi>
    <tradeName>SET DBR KT DIALYSE</tradeName>
    <deviceName>Assemblage DIALYSE STE</deviceName>
    <manufacturerName>HEMODIA SAS</manufacturerName>
    <manufacturerSrn>FR-PR-000007189</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F0303</emdnCode>
    <emdnDescription>HAEMODIALYSIS KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10112_A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:43:34.547Z</lastUpdated>
  </row>
  <row>
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    <basicUdiDi>3661379ASS13DIA01F5</basicUdiDi>
    <tradeName>SET DIALYSE PERITONEALE</tradeName>
    <deviceName>Assemblage DIALYSE STE</deviceName>
    <manufacturerName>HEMODIA SAS</manufacturerName>
    <manufacturerSrn>FR-PR-000007189</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F0303</emdnCode>
    <emdnDescription>HAEMODIALYSIS KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8127_B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:43:30.808Z</lastUpdated>
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    <udiDi>08906183410020</udiDi>
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    <tradeName>08906183410020</tradeName>
    <deviceName>Concentrated Haemodialysis Solution</deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL2-R-101-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:57:04.769Z</lastUpdated>
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</eudamedExport>