Skip to content

Leica Biosystems Newcastle, Limited

Active in EUDAMED

Registered as Leica Biosystems Newcastle Ltd in EUDAMED

Also registered as Leica Biosystems Newcastle Ltd

United Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000020595 FEI 3004859032

Devices
959
Registrations
EUDAMEDFDA
FDA recalls
1

What Leica Biosystems Newcastle, Limited makes

The company manufactures in vitro diagnostic (IVD) antibody reagents and automated immunohistochemistry (IHC) systems for tissue analysis, including cytokeratin, estrogen/progesterone receptors, kappa/lambda light chains, Ki67, CD45, CD117, and CD20 markers. These products support pathology workflows for cancer diagnostics, cell marker identification, and receptor assessment in clinical laboratories.

The portfolio includes Class I, Class II, and Class III devices, all listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue959

Newest first, rows 951-959 of 959

Search and filter all 959 devices

  • Ncl-L-Tyros

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-Des-Derii

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-Langerin

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • ChromoPlex 1 Dual Detection for BOND-PRIME Ref DS9397

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Novocastra Hematoxylin Ref RE7107

    Active Regimes: CE IVDR Registry: EUDAMEDGUDID Class:A

  • Ncl-L-Chrom-430

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-CA125

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:IVD General

  • Ncl-L-Pgr-312/2

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • ERBB2 (17q12)/SE 17 Ref KBI-10701

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

Showing 951-959 of 959

Company details

EUDAMED SRN
GB-MF-000020595
FDA FEI number
3004859032
EU VAT number
GB 974 9710 70
EUDAMED status
Active
EUDAMED registered name
Leica Biosystems Newcastle Ltd
Registered address
Balliol Business Park, NE12 8EW, Newcastle Upon Tyne, United Kingdom (ex Northern Ireland)
PRRC contact
Lynne Dobson(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredIVDR 1next expiry 7 Jun 2031

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • IVDR 739320 Active Reissued

    Quality management system EU IVDR

    Issued
    1 Jun 2026
    Expires
    7 Jun 2031
    Valid from
    8 Jun 2026

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Leica Biosystems Newcastle, Limited, initiated on 2013-07-31. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2013

    • 31 Jul 2013 Z-0717-2014 Class II Terminated The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensitivity and/or obstructions to fluid delivery to the slide. Distribution: Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI,…
      Full distribution text Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and WV); and Internationally to Chile, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Sweden, Switzerland, Poland, Romania, Singapore, South Korea, and the United Kingdom.

Frequently asked questions

How many devices does Leica Biosystems Newcastle, Limited have in the registry?

The registry currently lists 959 devices for Leica Biosystems Newcastle, Limited. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for Leica Biosystems Newcastle, Limited?

FDA recall records list 1 recall initiated by Leica Biosystems Newcastle, Limited, the most recent initiated on 31 Jul 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Leica Biosystems Newcastle, Limited?

EUDAMED lists 1 certificate for Leica Biosystems Newcastle, Limited (quality management system) under IVDR. The most recent was issued on 1 Jun 2026.

Generated automatically from registry data and not verified by a human reviewer.