<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05904365620291</udiDi>
    <basicUdiDi>5904365620PBSBL</basicUdiDi>
    <tradeName>PBS zbuforowany fizjolicziczny roztwór soli do badań serogicznych pH 6,9 (2litry)</tradeName>
    <deviceName>PBS – buffered salt solution pH 6,9</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>655</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:38:17.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620321</udiDi>
    <basicUdiDi>5904365620MEH4</basicUdiDi>
    <tradeName>2-ME Roztwór do różnicowania przeciwciał klasy IgM i IgG</tradeName>
    <deviceName>2-ME solution for the differrentiation of IgM and IgG antibodies</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>918</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:30.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620314</udiDi>
    <basicUdiDi>5904365620ELGS</basicUdiDi>
    <tradeName>Odczynniki do elucji. Kwaśna glicyna/ 10% EDTA/ 1M TRIS</tradeName>
    <deviceName>Reagents for elution The acid glycine, 10% EDTA, 1M TRIS</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>919</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:29.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620284</udiDi>
    <basicUdiDi>5904365620PBSBL</basicUdiDi>
    <tradeName>PBS zbuforowany fizjologiczny roztwór soli do badań serologicznych pH 6,9</tradeName>
    <deviceName>PBS – buffered salt solution pH 6,9</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:29.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620277</udiDi>
    <basicUdiDi>5904365620LISSM99</basicUdiDi>
    <tradeName>LISS-M (low ionic strenght solution medium) jest roztworem soli o niskiej sile jonowej,  wystandaryzowanych  wartościach  pH   i  osmolalności, stosowany jest do przemywania i sporządzania zawiesin krwinek czerwonych</tradeName>
    <deviceName>LISS - M Modified low ionic strenght salt solution</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>911</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:25.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620260</udiDi>
    <basicUdiDi>5904365620LISSL97</basicUdiDi>
    <tradeName>LISS-L standaryzowany roztwór soli o niskiej sile jonowej do badań serologicznych</tradeName>
    <deviceName>LISS - L Low ionic strenght salt solution</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:24.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620253</udiDi>
    <basicUdiDi>5904365620PEGB5</basicUdiDi>
    <tradeName>PEG roztwór glikolu polietylenowego do pośredniego testu antyglobulinowego</tradeName>
    <deviceName>PEG - Polyethylene glycol solution for indirect antiglobulin test</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:23.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620239</udiDi>
    <basicUdiDi>5904365620KOLBL</basicUdiDi>
    <tradeName>Surowica Grupy AB</tradeName>
    <deviceName>AB Group Serum</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>663</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:22.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620017</udiDi>
    <basicUdiDi>B-05904365620017</basicUdiDi>
    <tradeName>Konserwowane Krwinki Wzorcowe do układu ABO</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></emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>508</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620024</udiDi>
    <basicUdiDi>B-05904365620024</basicUdiDi>
    <tradeName>Konserwowane Krwinki Wzorcowe do układu ABO I</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></emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>576</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620031</udiDi>
    <basicUdiDi>B-05904365620031</basicUdiDi>
    <tradeName>Konserwowane Krwinki Wzorcowe do wykrywania przeciwciał</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTIBODY 3 CELL SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>509</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620048</udiDi>
    <basicUdiDi>B-05904365620048</basicUdiDi>
    <tradeName>Konserwowane Krwinki Wzorcowe do identyfikacji przeciwciał</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTIBODY IDENTIFICATION CELL PANELS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620055</udiDi>
    <basicUdiDi>B-05904365620055</basicUdiDi>
    <tradeName>Konserwowane Krwinki Wzorcowe do identyfikacji przeciwciał PLUS</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTIBODY IDENTIFICATION CELL PANELS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>913</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620062</udiDi>
    <basicUdiDi>B-05904365620062</basicUdiDi>
    <tradeName>Standaryzowane Krwinki Wzorcowe typ PBS-VERA do układu ABO</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></emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>511</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620079</udiDi>
    <basicUdiDi>B-05904365620079</basicUdiDi>
    <tradeName>Standaryzowane Krwinki Wzorcowe do układu ABO</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></emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620086</udiDi>
    <basicUdiDi>B-05904365620086</basicUdiDi>
    <tradeName>Standaryzowane Krwinki Wzorcowe typ LISS-VERA do wykrywania przeciwciał</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTIBODY 3 CELL SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>512</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620093</udiDi>
    <basicUdiDi>B-05904365620093</basicUdiDi>
    <tradeName>Standaryzowane Krwinki Wzorcowe opłaszczone do kontroli BTA</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620109</udiDi>
    <basicUdiDi>B-05904365620109</basicUdiDi>
    <tradeName>Standaryzowane Krwinki Wzorcowe O RhD+ opłaszczone przeciwciałami anty-D</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>515</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.377Z</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></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>915</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904365620123</udiDi>
    <basicUdiDi>B-05904365620123</basicUdiDi>
    <tradeName>Zestaw Próbek Kontrolnych ZPK</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></emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>926</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:35:08.332Z</lastUpdated>
  </row>
</eudamedExport>