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    <deviceName>Dry Haemodialysis Concentrate</deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-D-301-32.03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:57:02.372Z</lastUpdated>
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    <udiDi>05310001270506</udiDi>
    <basicUdiDi>B-05310001270506</basicUdiDi>
    <tradeName>AMINAL CITRATE CD-1,50 5 L</tradeName>
    <deviceName>Concentrate for Haemodialysis</deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010278</reference>
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    <udiDi>05310001270384</udiDi>
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    <tradeName>AMINAL CITRATE CD 5 L</tradeName>
    <deviceName>Concentrate for Haemodialysis</deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
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    <reference>1010266</reference>
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    <lastUpdated>2026-07-17T19:53:01.089Z</lastUpdated>
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    <udiDi>05310001246280</udiDi>
    <basicUdiDi>B-05310001246280</basicUdiDi>
    <tradeName>AMINAL-BCD 0,50/1 5 L</tradeName>
    <deviceName>Concentrate for Haemodialysis</deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
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    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1008198</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:52:59.492Z</lastUpdated>
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    <udiDi>05310001250119</udiDi>
    <basicUdiDi>B-05310001250119</basicUdiDi>
    <tradeName>AMINAL-BC 0,50 5 L</tradeName>
    <deviceName>Concentrate for Haemodialysis</deviceName>
    <manufacturerName>ALKALOID AD Skopje</manufacturerName>
    <manufacturerSrn>MK-MF-000027533</manufacturerSrn>
    <authorisedRepresentativeName>ALKALOID - INT družba za trgovino in storitve d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000024261</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1008570</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:52:57.128Z</lastUpdated>
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    <udiDi>08033772326780</udiDi>
    <basicUdiDi>803377232HMF-SETE6</basicUdiDi>
    <tradeName>Linea per trattamento di ECCO2R + HF</tradeName>
    <deviceName>SET FOR HEMOFILTRATION</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>M03982</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:46:46.326Z</lastUpdated>
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    <udiDi>08033772326162</udiDi>
    <basicUdiDi>803377232HMF-RAY-M7</basicUdiDi>
    <tradeName>DP230HE Hemofilter</tradeName>
    <deviceName>HEMOFILTRATION DEVICES</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M03907</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:46:44.725Z</lastUpdated>
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    <udiDi>04806538161321</udiDi>
    <basicUdiDi>480653816001CK</basicUdiDi>
    <tradeName>BIONIC FISTULA NEEDLE</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040-VGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:31.022Z</lastUpdated>
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    <udiDi>08906183411225</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X DEXTROSE</tradeName>
    <deviceName></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>DHC2-D-101-2.336</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:26.701Z</lastUpdated>
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    <udiDi>08906183411409</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X DEXTROSE</tradeName>
    <deviceName></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>DHC2-D-101-22.09</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:26.324Z</lastUpdated>
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    <udiDi>04806538161307</udiDi>
    <basicUdiDi>480653816001CK</basicUdiDi>
    <tradeName>BIONIC FISTULA NEEDLE</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>050-AGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:26.136Z</lastUpdated>
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    <udiDi>08906183412994</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X DEXTROSE</tradeName>
    <deviceName></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>
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    <emdnCode>F040101</emdnCode>
    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-D-101-0.895</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:18.609Z</lastUpdated>
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    <udiDi>08906183413007</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X DEXTROSE</tradeName>
    <deviceName></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>
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    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-D-101-8.47</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:18.405Z</lastUpdated>
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    <udiDi>04806538161338</udiDi>
    <basicUdiDi>480653816001CK</basicUdiDi>
    <tradeName>BIONIC FISTULA NEEDLE</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>050-VGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:17.533Z</lastUpdated>
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    <udiDi>08906183410754</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
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    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-R-102-9.885</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:17.501Z</lastUpdated>
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    <udiDi>08906183411232</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surni Labs</manufacturerName>
    <manufacturerSrn>IN-MF-000041295</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
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    <emdnDescription>DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC2-R-102-1.977</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:16.915Z</lastUpdated>
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    <udiDi>04806538161345</udiDi>
    <basicUdiDi>480653816001CK</basicUdiDi>
    <tradeName>BIONIC FISTULA NEEDLE</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>830-AGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:16.765Z</lastUpdated>
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    <basicUdiDi>480653816001CK</basicUdiDi>
    <tradeName>BIONIC FISTULA NEEDLE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>JMS HEALTHCARE PHL, INC</manufacturerName>
    <manufacturerSrn>PH-MF-000024060</manufacturerSrn>
    <authorisedRepresentativeName>Bionic Medizintechnik GmbH</authorisedRepresentativeName>
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    <emdnCode>F020101</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, ONE NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>830-VGAM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:15.551Z</lastUpdated>
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    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X</tradeName>
    <deviceName></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>DHC2-R-102-0.895</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:15.315Z</lastUpdated>
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    <udiDi>08906183410761</udiDi>
    <basicUdiDi>890618341SLHCAPBPB3</basicUdiDi>
    <tradeName>DRYCONC 36.83X</tradeName>
    <deviceName></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>DHC2-R-103-9.975</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:43:14.915Z</lastUpdated>
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