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    <basicUdiDi>590649294ODBKLE</basicUdiDi>
    <tradeName>RapiHem Zestaw do szybkiego barwienia rozmazów krwi</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOLASA SPÓŁKA JAWNA</manufacturerName>
    <manufacturerSrn>PL-MF-000044993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0176.2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:16:49.999Z</lastUpdated>
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    <udiDi>05906492942819</udiDi>
    <basicUdiDi>590649294ODBKLE</basicUdiDi>
    <tradeName>RapiHem NIEBIESKI 500ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOLASA SPÓŁKA JAWNA</manufacturerName>
    <manufacturerSrn>PL-MF-000044993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1024.3</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:16:49.984Z</lastUpdated>
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    <udiDi>05906492942826</udiDi>
    <basicUdiDi>590649294ODBKLE</basicUdiDi>
    <tradeName>RapiHem CZERWONY 500 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOLASA SPÓŁKA JAWNA</manufacturerName>
    <manufacturerSrn>PL-MF-000044993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1023.3</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:16:49.944Z</lastUpdated>
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    <udiDi>05906492943205</udiDi>
    <basicUdiDi>590649294ODBKLE</basicUdiDi>
    <tradeName>Bufor rozcieńczający barwnik Giemsy (pH 7.0) 250 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOLASA SPÓŁKA JAWNA</manufacturerName>
    <manufacturerSrn>PL-MF-000044993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1040.7</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:16:49.561Z</lastUpdated>
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  <row>
    <udiDi>05906492943212</udiDi>
    <basicUdiDi>590649294ODBKLE</basicUdiDi>
    <tradeName>Bufor rozcieńczający barwnik Giemsy (pH 7.2) 250 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOLASA SPÓŁKA JAWNA</manufacturerName>
    <manufacturerSrn>PL-MF-000044993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1060.7</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:16:49.537Z</lastUpdated>
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  <row>
    <udiDi>05906492943229</udiDi>
    <basicUdiDi>590649294ODBKLE</basicUdiDi>
    <tradeName>Bufor rozcieńczający barwnik Giemsy (pH 6.8) 250 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KOLASA SPÓŁKA JAWNA</manufacturerName>
    <manufacturerSrn>PL-MF-000044993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1061.7</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:16:49.511Z</lastUpdated>
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  <row>
    <udiDi>14987562509079</udiDi>
    <basicUdiDi>4987562STROMATOLYSER4DLCC</basicUdiDi>
    <tradeName>STROMATOLYSER-4DL</tradeName>
    <deviceName>STROMATOLYSER -4DL</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>054-3321-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:43:01.377Z</lastUpdated>
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  <row>
    <udiDi>14987562505309</udiDi>
    <basicUdiDi>4987562LysercellWDFII2L</basicUdiDi>
    <tradeName>14987562505309</tradeName>
    <deviceName>Lysercell WDF II</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BY541589</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:43:00.571Z</lastUpdated>
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    <udiDi>00844509000648</udiDi>
    <basicUdiDi>0844509012EXT5Y</basicUdiDi>
    <tradeName>Streck</tradeName>
    <deviceName>Para 12 EXT - 18 x 2.5 mL (6 Low, 6 Normal, 6 High)</deviceName>
    <manufacturerName>Streck</manufacturerName>
    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>218750</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:20:42.799Z</lastUpdated>
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  <row>
    <udiDi>00844509000358</udiDi>
    <basicUdiDi>08445090STKRQM</basicUdiDi>
    <tradeName>Streck</tradeName>
    <deviceName>STaK-Chex Plus Retics - 4x4.5ml Low</deviceName>
    <manufacturerName>Streck</manufacturerName>
    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225485</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:20:39.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844509000280</udiDi>
    <basicUdiDi>08445090CX8Z</basicUdiDi>
    <tradeName>Streck</tradeName>
    <deviceName>Cell-Chex, 3 x 2.0 mL L1-UC, L1-CC, L2</deviceName>
    <manufacturerName>Streck</manufacturerName>
    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212420</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:20:38.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815762024153</udiDi>
    <basicUdiDi>0815762020RIBS</basicUdiDi>
    <tradeName>R&amp;D Retic-I</tradeName>
    <deviceName>R&amp;D Retic-I</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Many</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:19:38.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815762023446</udiDi>
    <basicUdiDi>0815762028CPC3</basicUdiDi>
    <tradeName>CBC-CAL PLUS</tradeName>
    <deviceName>NCAL1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Many</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:19:38.022Z</lastUpdated>
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  <row>
    <udiDi>00815762020674</udiDi>
    <basicUdiDi>0815762020CT02A</basicUdiDi>
    <tradeName>Tech-Cal</tradeName>
    <deviceName>Tech-Cal</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0CT010TA3</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:19:37.207Z</lastUpdated>
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    <udiDi>00811476010154</udiDi>
    <basicUdiDi>081147601Reagents3Z2</basicUdiDi>
    <tradeName>CHRONO-PAR® Arachidonic Acid</tradeName>
    <deviceName>Reagents</deviceName>
    <manufacturerName>Chrono-log Corp</manufacturerName>
    <manufacturerSrn>US-MF-000018631</manufacturerSrn>
    <authorisedRepresentativeName>BioTop Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012565</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>390 Arachidonic Acid</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:10:44.943Z</lastUpdated>
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    <udiDi>00811476010123</udiDi>
    <basicUdiDi>081147601Reagents5Z6</basicUdiDi>
    <tradeName>Lyophilized Human Platelets, TBS</tradeName>
    <deviceName>Reagent</deviceName>
    <manufacturerName>Chrono-log Corp</manufacturerName>
    <manufacturerSrn>US-MF-000018631</manufacturerSrn>
    <authorisedRepresentativeName>BioTop Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012565</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P/N 299-2 Lyophilized Human Platelets, TBS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:10:43.802Z</lastUpdated>
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    <udiDi>00811476010079</udiDi>
    <basicUdiDi>081147601Reagents4Z4</basicUdiDi>
    <tradeName>CHRONO-PAR® CHRONO-LUME®</tradeName>
    <deviceName>Reagent</deviceName>
    <manufacturerName>Chrono-log Corp</manufacturerName>
    <manufacturerSrn>US-MF-000018631</manufacturerSrn>
    <authorisedRepresentativeName>BioTop Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012565</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>395 CHRONO-LUME®</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:10:41.480Z</lastUpdated>
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  <row>
    <udiDi>00811476010055</udiDi>
    <basicUdiDi>081147601Reagents1YW</basicUdiDi>
    <tradeName>CHRONO-PAR® Collagen</tradeName>
    <deviceName>Reagent</deviceName>
    <manufacturerName>Chrono-log Corp</manufacturerName>
    <manufacturerSrn>US-MF-000018631</manufacturerSrn>
    <authorisedRepresentativeName>BioTop Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012565</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>385 Collagen</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:10:39.342Z</lastUpdated>
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    <udiDi>00811476010017</udiDi>
    <basicUdiDi>081147601Reagents2YY</basicUdiDi>
    <tradeName>CHRONO-LOG° vW Reference Plasma Deficient</tradeName>
    <deviceName>Reagents</deviceName>
    <manufacturerName>Chrono-log Corp</manufacturerName>
    <manufacturerSrn>US-MF-000018631</manufacturerSrn>
    <authorisedRepresentativeName>BioTop Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012565</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>299-4 vW Reference Plasma Deficient</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:10:38.560Z</lastUpdated>
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    <udiDi>00811476010000</udiDi>
    <basicUdiDi>081147601Reagents53</basicUdiDi>
    <tradeName>00811476010000</tradeName>
    <deviceName>Reagents</deviceName>
    <manufacturerName>Chrono-log Corp</manufacturerName>
    <manufacturerSrn>US-MF-000018631</manufacturerSrn>
    <authorisedRepresentativeName>BioTop Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012565</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>299-1 Ristocetin</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:10:36.938Z</lastUpdated>
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