<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05904365620246</udiDi>
    <basicUdiDi>B-05904365620246</basicUdiDi>
    <tradeName>Dolichotest</tradeName>
    <deviceName>Dolichotest</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030199</emdnCode>
    <emdnDescription>ABO TYPING TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>133</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:20:11.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620222</udiDi>
    <basicUdiDi>B-05904365620222</basicUdiDi>
    <tradeName>Odczynnik anty-IgG</tradeName>
    <deviceName>Anti-IgG reagent</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030305</emdnCode>
    <emdnDescription>MONOSPECIFIC ANTIHUMAN SERUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>899</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:20:10.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620215</udiDi>
    <basicUdiDi>B-05904365620215</basicUdiDi>
    <tradeName>Surowica Antyglobulinowa Poliwalentna (10x10ml)</tradeName>
    <deviceName>Polyvalent anti-human globulin serum (10x10ml)</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030304</emdnCode>
    <emdnDescription>POLYSPECIFIC ANTIHUMAN SERUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>912</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:20:09.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620208</udiDi>
    <basicUdiDi>B-05904365620208</basicUdiDi>
    <tradeName>Surowica Antyglobulinowa Poliwalentna (1x5ml)</tradeName>
    <deviceName>Polyvalent anti-human globulin serum (1x5ml)</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030304</emdnCode>
    <emdnDescription>POLYSPECIFIC ANTIHUMAN SERUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103/1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:20:06.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620192</udiDi>
    <basicUdiDi>B-05904365620192</basicUdiDi>
    <tradeName>Surowica Antyglobulinowa Poliwalentna (10x5ml)</tradeName>
    <deviceName>Polyvalent anti-human globulin serum (10x5ml)</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030304</emdnCode>
    <emdnDescription>POLYSPECIFIC ANTIHUMAN SERUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103/10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:20:05.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620185</udiDi>
    <basicUdiDi>B-05904365620185</basicUdiDi>
    <tradeName>Standard anty-D MIKRO (1x2ml)</tradeName>
    <deviceName>Standard anti-D MIKRO (1x2ml)</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910/1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:20:04.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620178</udiDi>
    <basicUdiDi>B-05904365620178</basicUdiDi>
    <tradeName>Standard anty-D MIKRO (10x2ml)</tradeName>
    <deviceName>Standard anti-D MIKRO (10x2ml)</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910/10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:20:02.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620154</udiDi>
    <basicUdiDi>B-05904365620154</basicUdiDi>
    <tradeName>Standard anty-D (10x2ml)</tradeName>
    <deviceName>Standard anti-D (10x2ml)</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109/10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:20:00.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620147</udiDi>
    <basicUdiDi>B-05904365620147</basicUdiDi>
    <tradeName>Papaina ST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103030307</emdnCode>
    <emdnDescription>ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:46.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620130</udiDi>
    <basicUdiDi>B-05904365620130</basicUdiDi>
    <tradeName>Zestaw Próbek Kontrolnych do codziennej kontroli odczynników diagnostycznych i krwinek wzorcowych do układu ABO i RhD ZPK I</tradeName>
    <deviceName>SET OF CONTROL SAMPLES I – SCS I</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>931</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:45.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620123</udiDi>
    <basicUdiDi>B-05904365620123</basicUdiDi>
    <tradeName>Zestaw Próbek Kontrolnych ZPK</tradeName>
    <deviceName>SET OF CONTROL SAMPLES – SCS</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>926</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:44.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620116</udiDi>
    <basicUdiDi>B-05904365620116</basicUdiDi>
    <tradeName>Standaryzowane Krwinki Wzorcowe O RhD+ opłaszczone przeciwciałami anty-D GOTOWE DO UŻYTKU</tradeName>
    <deviceName>Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies READY TO USE</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030401</emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>915</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:42.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620109</udiDi>
    <basicUdiDi>B-05904365620109</basicUdiDi>
    <tradeName>Standaryzowane Krwinki Wzorcowe O RhD+ opłaszczone przeciwciałami anty-D</tradeName>
    <deviceName>Coated Standardized Red Blood Cells ORhD+ with anti-D antibodies</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030401</emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>515</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:40.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620093</udiDi>
    <basicUdiDi>B-05904365620093</basicUdiDi>
    <tradeName>Standaryzowane Krwinki Wzorcowe opłaszczone do kontroli BTA</tradeName>
    <deviceName>Coated Standardized Red Blood Cells to direct antiglobulin test control</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030401</emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:38.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620086</udiDi>
    <basicUdiDi>B-05904365620086</basicUdiDi>
    <tradeName>Standaryzowane Krwinki Wzorcowe typ LISS-VERA do wykrywania przeciwciał</tradeName>
    <deviceName>Standardized Red Blood Cells. Set type LISS-VERA for the antibodies detection</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030308</emdnCode>
    <emdnDescription>ANTIBODY 3 CELL SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>512</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:37.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620079</udiDi>
    <basicUdiDi>B-05904365620079</basicUdiDi>
    <tradeName>Standaryzowane Krwinki Wzorcowe do układu ABO</tradeName>
    <deviceName>Standardized Red Blood Cells for the ABO group system</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030101</emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:36.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620062</udiDi>
    <basicUdiDi>B-05904365620062</basicUdiDi>
    <tradeName>Standaryzowane Krwinki Wzorcowe typ PBS-VERA do układu ABO</tradeName>
    <deviceName>Standardized Red Blood Cells. Set type PBS-VERA for the ABO system definition</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030101</emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>511</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:33.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620055</udiDi>
    <basicUdiDi>B-05904365620055</basicUdiDi>
    <tradeName>Konserwowane Krwinki Wzorcowe do identyfikacji przeciwciał PLUS</tradeName>
    <deviceName>Preserved Standard Red Blood Cells. Set for the antibody identification PLUS</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030303</emdnCode>
    <emdnDescription>ANTIBODY IDENTIFICATION CELL PANELS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>913</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:32.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620048</udiDi>
    <basicUdiDi>B-05904365620048</basicUdiDi>
    <tradeName>Konserwowane Krwinki Wzorcowe do identyfikacji przeciwciał</tradeName>
    <deviceName>Preserved Standard Red Blood Cells. Set for the antibody identification</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030303</emdnCode>
    <emdnDescription>ANTIBODY IDENTIFICATION CELL PANELS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:31.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620031</udiDi>
    <basicUdiDi>B-05904365620031</basicUdiDi>
    <tradeName>Konserwowane Krwinki Wzorcowe do wykrywania przeciwciał</tradeName>
    <deviceName>Preserved Standard Red Blood Cells. Set for the antibodies detection</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030308</emdnCode>
    <emdnDescription>ANTIBODY 3 CELL SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>509</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:19:29.788Z</lastUpdated>
  </row>
</eudamedExport>