<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060242470219</udiDi>
    <basicUdiDi>B-05060242470219</basicUdiDi>
    <tradeName>ALBAclone® Anti-N</tradeName>
    <deviceName>ALBAclone® Anti-N</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z176</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:16:25.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242470202</udiDi>
    <basicUdiDi>B-05060242470202</basicUdiDi>
    <tradeName>ALBAclone® Anti-M</tradeName>
    <deviceName>ALBAclone® Anti-M</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z171</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:16:25.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242470196</udiDi>
    <basicUdiDi>B-05060242470196</basicUdiDi>
    <tradeName>ALBAclone® Anti-Jkb</tradeName>
    <deviceName>ALBAclone® Anti-Jkb</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z166</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:16:23.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242470189</udiDi>
    <basicUdiDi>B-05060242470189</basicUdiDi>
    <tradeName>ALBAclone® Anti-Jka</tradeName>
    <deviceName>ALBAclone® Anti-Jka</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z162</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:16:21.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060242470141</udiDi>
    <basicUdiDi>B-05060242470141</basicUdiDi>
    <tradeName>ALBAclone® Anti-k (cellano)</tradeName>
    <deviceName>ALBAclone® Anti-k (cellano)</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z137</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:16:19.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060168051189</udiDi>
    <basicUdiDi>B-05060168051189</basicUdiDi>
    <tradeName>Monoclonal D Negative Control (1 X 10ml)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lorne Laboratories Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000029354</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650010</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:58:12.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060168051011</udiDi>
    <basicUdiDi>B-05060168051011</basicUdiDi>
    <tradeName>Anti-A,B Monoclonal (1 X 10ml)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lorne Laboratories Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000029354</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030102</emdnCode>
    <emdnDescription>ABO SERA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620010</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:58:11.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060168050939</udiDi>
    <basicUdiDi>B-05060168050939</basicUdiDi>
    <tradeName>Anti-B Monoclonal (1 X 10ml)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lorne Laboratories Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000029354</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030102</emdnCode>
    <emdnDescription>ABO SERA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610010</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:58:10.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060168050854</udiDi>
    <basicUdiDi>B-05060168050854</basicUdiDi>
    <tradeName>Anti-A Monoclonal (1 X 10ml)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lorne Laboratories Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000029354</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030102</emdnCode>
    <emdnDescription>ABO SERA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600010</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:58:06.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331329714</udiDi>
    <basicUdiDi>B-05055331329714</basicUdiDi>
    <tradeName>S-100 EP32 7 mL</tradeName>
    <deviceName>BOND Ready-to-Use Primary Antibody S-100 (EP32)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:16:32.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331329707</udiDi>
    <basicUdiDi>B-05055331329707</basicUdiDi>
    <tradeName>NCL-L-S100-167</tradeName>
    <deviceName>Novocastra Liquid Rabbit Monoclonal Antibody S100 (EP32)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCL-L-S100-167</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:16:31.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331329684</udiDi>
    <basicUdiDi>B-05055331329684</basicUdiDi>
    <tradeName>p16 6H12 7 mL</tradeName>
    <deviceName>BOND Ready-to-Use Primary Antibody p16 (6H12)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:16:30.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331328908</udiDi>
    <basicUdiDi>B-05055331328908</basicUdiDi>
    <tradeName>Programmed Death Ligand 1 73-10 7 mL</tradeName>
    <deviceName>BOND Ready-to-Use Primary Antibody Programmed Death Ligand 1 (73-10)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0832</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:16:26.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331328809</udiDi>
    <basicUdiDi>B-05055331328809</basicUdiDi>
    <tradeName>NCL-L-MSH2-612</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Mismatch Repair Protein 2 (MSH2)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCL-L-MSH2-612</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:16:25.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331328410</udiDi>
    <basicUdiDi>B-05055331328410</basicUdiDi>
    <tradeName>NCL-L-HHV8-LNA</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Human Herpesvirus (Type 8) (latent nuclear antigen)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCL-L-HHV8-LNA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:16:24.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331328335</udiDi>
    <basicUdiDi>B-05055331328335</basicUdiDi>
    <tradeName>Cytokeratin AE1/AE3 7 mL</tradeName>
    <deviceName>BOND Ready-to-Use Primary Antibody Cytokeratin (AE1/AE3)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0094</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:16:24.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331328311</udiDi>
    <basicUdiDi>B-05055331328311</basicUdiDi>
    <tradeName>Herpesvirus (Type 8) 13B10 7 mL</tradeName>
    <deviceName>BOND Ready-to-Use Primary Antibody Human Herpesvirus (Type 8)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:16:20.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331328243</udiDi>
    <basicUdiDi>B-05055331328243</basicUdiDi>
    <tradeName>NCL-L-PTH-488</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Parathyroid Hormone</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCL-L-PTH-488</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:16:18.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331328236</udiDi>
    <basicUdiDi>B-05055331328236</basicUdiDi>
    <tradeName>NCL-L-LANGERIN</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Langerin</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCL-L-LANGERIN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:16:17.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331328229</udiDi>
    <basicUdiDi>B-05055331328229</basicUdiDi>
    <tradeName>NCL-L-p57</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody p57 Protein (Kip2)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCL-L-p57</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:16:16.902Z</lastUpdated>
  </row>
</eudamedExport>