<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05055331303547</udiDi>
    <basicUdiDi>B-05055331303547</basicUdiDi>
    <tradeName>Lambda Probe 5.5 mL</tradeName>
    <deviceName>BOND Ready-to-Use ISH Lambda Probe</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>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB0669</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:23.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331303530</udiDi>
    <basicUdiDi>B-05055331303530</basicUdiDi>
    <tradeName>DNA Positive Control Probe 6.25 mL</tradeName>
    <deviceName>BOND Ready-to-Use ISH DNA Positive Control Probe</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>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB0682</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:22.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331303523</udiDi>
    <basicUdiDi>B-05055331303523</basicUdiDi>
    <tradeName>DNA Negative Control 6.25 mL</tradeName>
    <deviceName>BOND Ready-to-Use ISH DNA Negative Control</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>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB0731</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:18.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331303516</udiDi>
    <basicUdiDi>B-05055331303516</basicUdiDi>
    <tradeName>HPV Probe (subtypes 6, 11) 6.25 mL</tradeName>
    <deviceName>BOND Ready-to-Use ISH HPV Probe (Subtypes 6, 11)</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>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB0780</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:17.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331303509</udiDi>
    <basicUdiDi>B-05055331303509</basicUdiDi>
    <tradeName>RNA Positive Control probe 5.5 mL</tradeName>
    <deviceName>BOND Ready-to-Use ISH RNA Positive Control Probe</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>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB0785</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:16.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331303493</udiDi>
    <basicUdiDi>B-05055331303493</basicUdiDi>
    <tradeName>RNA Negative Control Probe</tradeName>
    <deviceName>BOND Ready-to-Use ISH RNA Negative Control Probe</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>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB0809</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:15.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331303486</udiDi>
    <basicUdiDi>B-05055331303486</basicUdiDi>
    <tradeName>HPV Probe (subtypes 16, 18, 31, 33, 51) 6.25 mL</tradeName>
    <deviceName>BOND Ready-to-Use ISH HPV Probe (Subtypes 16, 18, 31, 33, 51)</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>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PB0829</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:11.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331303271</udiDi>
    <basicUdiDi>B-05055331303271</basicUdiDi>
    <tradeName>NCL-L-PGP9.5</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Protein Gene Product 9.5</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-PGP9.5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:10.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331303066</udiDi>
    <basicUdiDi>B-05055331303066</basicUdiDi>
    <tradeName>NCL-L-PGR-312/2</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor</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-PGR-312/2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:09.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331302793</udiDi>
    <basicUdiDi>B-05055331302793</basicUdiDi>
    <tradeName>NCL-L-PLAP-8A9</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Placental Alkaline Phosphatase</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-PLAP-8A9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:08.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331301482</udiDi>
    <basicUdiDi>B-05055331301482</basicUdiDi>
    <tradeName>NCL-SPEC1</tradeName>
    <deviceName>Novocastra Lyophilized Mouse Monoclonal Antibody Spectrin</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-SPEC1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:04.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331301352</udiDi>
    <basicUdiDi>B-05055331301352</basicUdiDi>
    <tradeName>NCL-L-SYNAP-299</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Synaptophysin</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-SYNAP-299</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:03.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331301208</udiDi>
    <basicUdiDi>B-05055331301208</basicUdiDi>
    <tradeName>NCL-L-TDT-339</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Terminal Deoxynucleotidyl Transferase</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-TDT-339</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:03.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331301291</udiDi>
    <basicUdiDi>B-05055331301291</basicUdiDi>
    <tradeName>BOND Oracle HER2 IHC System</tradeName>
    <deviceName>BOND™ Oracle™ HER2 IHC 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>W01030711</emdnCode>
    <emdnDescription>IMMUNOHISTOLOGY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA9145</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:08:02.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331300584</udiDi>
    <basicUdiDi>B-05055331300584</basicUdiDi>
    <tradeName>NCL-L-TYROS</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Tyrosinase</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-TYROS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:07:58.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331300935</udiDi>
    <basicUdiDi>B-05055331300935</basicUdiDi>
    <tradeName>NCL-L-TPO</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Thyroid Peroxidase</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-TPO</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:07:56.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331300676</udiDi>
    <basicUdiDi>B-05055331300676</basicUdiDi>
    <tradeName>NCL-L-TTF-1</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Thyroid Transcription Factor-1</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>NCL-L-TTF-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:07:55.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331300294</udiDi>
    <basicUdiDi>B-05055331300294</basicUdiDi>
    <tradeName>NCL-L-VIM-V9</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Vimentin</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-VIM-V9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:07:39.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055331300096</udiDi>
    <basicUdiDi>B-05055331300096</basicUdiDi>
    <tradeName>NCL-L-WT1-562</tradeName>
    <deviceName>Novocastra Liquid Mouse Monoclonal Antibody Wilms’ Tumor</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-WT1-562</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:07:37.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>04589448510082</udiDi>
    <basicUdiDi>B-04589448510082</basicUdiDi>
    <tradeName>PL Chip</tradeName>
    <deviceName>PL Chip</deviceName>
    <manufacturerName>ZACROS Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000025159</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020499</emdnCode>
    <emdnDescription>PRIMARY HEMOSTASIS/PLATELET FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:58:29.572Z</lastUpdated>
  </row>
</eudamedExport>