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<eudamedExport entity="devices">
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    <tradeName>Granulat do separacji surowicy - 300g</tradeName>
    <deviceName>Granulat do separacji surowicy</deviceName>
    <manufacturerName>MEDLAB-PRODUCTS Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000028388</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029001</emdnCode>
    <emdnDescription>BLOOD COMPONENTS SEPARATORS, PLASTIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32-9300-0</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:03:25.855Z</lastUpdated>
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    <udiDi>04987486039129</udiDi>
    <basicUdiDi>4987486BC0108243GS</basicUdiDi>
    <tradeName>Centrifuge Tube (for SPOTCHEM EZ)</tradeName>
    <deviceName>Centrifuge Tube (for SPOTCHEM EZ)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108243</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:52.386Z</lastUpdated>
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    <udiDi>04987486039105</udiDi>
    <basicUdiDi>4987486BC0108241GN</basicUdiDi>
    <tradeName>Whole Blood Sample Tube</tradeName>
    <deviceName>Whole Blood Sample Tube</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108241</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:51.581Z</lastUpdated>
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  <row>
    <udiDi>04987486039099</udiDi>
    <basicUdiDi>4987486BC0108240GL</basicUdiDi>
    <tradeName>Centrifuge Cup (for D-Concept)</tradeName>
    <deviceName>Centrifuge Cup (for D-Concept)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:49.977Z</lastUpdated>
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  <row>
    <udiDi>04987486039075</udiDi>
    <basicUdiDi>4987486BC0108238GZ</basicUdiDi>
    <tradeName>Cuvette (heparin)</tradeName>
    <deviceName>Cuvette (heparin)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108238</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:47.584Z</lastUpdated>
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  <row>
    <udiDi>08055510560003</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO PRESSIONE SERIGRAFATO 150 ml</tradeName>
    <deviceName>CONTENITORI PER CAMPIONI ISTOLOGICI</deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:43:28.282Z</lastUpdated>
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  <row>
    <udiDi>08055510561505</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO VITE 30 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3705</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:07.261Z</lastUpdated>
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    <udiDi>08055510561512</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO VITE 60 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3707</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:07.142Z</lastUpdated>
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  <row>
    <udiDi>08055510561536</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO VITE 120 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:07.104Z</lastUpdated>
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  <row>
    <udiDi>08055510561543</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO VITE 160 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:07.066Z</lastUpdated>
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  <row>
    <udiDi>08055510561567</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO VITE 500 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:07.011Z</lastUpdated>
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  <row>
    <udiDi>08055510561574</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO VITE 1000 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:06.894Z</lastUpdated>
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    <udiDi>08055510561581</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO VITE CON SUPERFICIE DI SCRITTURA 150 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0157</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:06.862Z</lastUpdated>
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    <udiDi>08055510561598</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO VITE CON SUPERFICIE DI SCRITTURA 200 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:06.842Z</lastUpdated>
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    <udiDi>08055510561604</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO VITE CON ETICHETTA 30 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:06.812Z</lastUpdated>
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    <udiDi>08055510561611</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO VITE CON ETICHETTA 60 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:06.788Z</lastUpdated>
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    <udiDi>08055510561628</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE PP TAPPO VITE CON ETICHETTA 90 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4970</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:06.755Z</lastUpdated>
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    <udiDi>08055510561659</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE HDPE TAPPO VITE 5 ml</tradeName>
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    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:06.720Z</lastUpdated>
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    <udiDi>08055510561666</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE HDPE TAPPO VITE 10 ml</tradeName>
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    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3211</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:06.673Z</lastUpdated>
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    <udiDi>08055510561673</udiDi>
    <basicUdiDi>805551056cont_camp_istoKV</basicUdiDi>
    <tradeName>CONTENITORE HDPE TAPPO VITE 30 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kaltek S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000019573</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3212</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:50:06.548Z</lastUpdated>
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