<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05055331319340</udiDi>
    <basicUdiDi>B-05055331319340</basicUdiDi>
    <tradeName>Leica HER2 FISH Control Slides</tradeName>
    <deviceName>Leica HER2 FISH Control Slides</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>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA9123</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:14:13.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331319326</udiDi>
    <basicUdiDi>B-05055331319326</basicUdiDi>
    <tradeName>NCL-L-HMB45</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Melanoma Marker (HMB45)</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-HMB45</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:14:13.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331319128</udiDi>
    <basicUdiDi>B-05055331319128</basicUdiDi>
    <tradeName>Lambda Light Chain SHL53 7 mL</tradeName>
    <deviceName>BOND Ready-to-Use Primary Antibody Lambda Light Chain (SHL53)</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>PA0570</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:14:09.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331319111</udiDi>
    <basicUdiDi>B-05055331319111</basicUdiDi>
    <tradeName>Kappa Light Chain CH15 7 mL</tradeName>
    <deviceName>BOND Ready-to-Use Primary Antibody Kappa Light Chain (CH15)</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>PA0606</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:14:08.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331319104</udiDi>
    <basicUdiDi>B-05055331319104</basicUdiDi>
    <tradeName>Melanoma Marker HMB45 7 mL</tradeName>
    <deviceName>BOND Ready-to-Use Primary Antibody Melanoma Marker (HMB45)</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>PA0027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:14:07.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331319005</udiDi>
    <basicUdiDi>B-05055331319005</basicUdiDi>
    <tradeName>Leica HER2 FISH System - 30 Test</tradeName>
    <deviceName>Leica HER2 FISH System</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>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA9217</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:14:06.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331318572</udiDi>
    <basicUdiDi>B-05055331318572</basicUdiDi>
    <tradeName>NCL-L-MSA-594</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Muscle Specific Actin</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-MSA-594</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:14:02.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331318541</udiDi>
    <basicUdiDi>B-05055331318541</basicUdiDi>
    <tradeName>NCL-L-Hpylori</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Helicobacter pylori</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-HPYLORI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:14:01.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331318480</udiDi>
    <basicUdiDi>B-05055331318480</basicUdiDi>
    <tradeName>NCL-L-PMS2</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Mismatch Repair Protein (PMS2)</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-PMS2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:14:01.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331318466</udiDi>
    <basicUdiDi>B-05055331318466</basicUdiDi>
    <tradeName>NCL-L-CD123</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody CD123</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-CD123</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:14:00.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331318411</udiDi>
    <basicUdiDi>B-05055331318411</basicUdiDi>
    <tradeName>NCL-L-CALCITONIN</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Calcitonin</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-CALCITONIN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:13:56.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331318350</udiDi>
    <basicUdiDi>B-05055331318350</basicUdiDi>
    <tradeName>NCL-L-InhibinA</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Inhibin Alpha</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-InhibinA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:13:55.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331318312</udiDi>
    <basicUdiDi>B-05055331318312</basicUdiDi>
    <tradeName>NCL-L-CD99-187</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody CD99</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-CD99-187</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:13:54.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331318077</udiDi>
    <basicUdiDi>B-05055331318077</basicUdiDi>
    <tradeName>Immunoglobulin M 8H6 7 mL</tradeName>
    <deviceName>BOND Ready-to-Use Primary Antibody Immunoglobulin M (8H6)</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>PA0278</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:13:53.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331318015</udiDi>
    <basicUdiDi>B-05055331318015</basicUdiDi>
    <tradeName>Multiple Myeloma Oncogene 1</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0129</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:12:02.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331317858</udiDi>
    <basicUdiDi>B-05055331317858</basicUdiDi>
    <tradeName>Gastrin Polyclonal 7 mL</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PA0681</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:12:01.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331317414</udiDi>
    <basicUdiDi>B-05055331317414</basicUdiDi>
    <tradeName>NCL-L-AMACR</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Alpha-Methylacyl-CoA Racemase (AMACR, p504S)</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-AMACR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:12:00.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331317773</udiDi>
    <basicUdiDi>B-05055331317773</basicUdiDi>
    <tradeName>NCL-L-MUM1</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCL-L-MUM1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:11:59.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331317193</udiDi>
    <basicUdiDi>B-05055331317193</basicUdiDi>
    <tradeName>NCL-L-5D3</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCL-L-5D3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:11:47.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331317100</udiDi>
    <basicUdiDi>B-05055331317100</basicUdiDi>
    <tradeName>NCL-L-a-SARC</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Alpha-Sarcoglycan (Adhalin)</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-a-SARC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:11:45.101Z</lastUpdated>
  </row>
</eudamedExport>