EUDAMED update: Jan 12, 2026

Leica Biosystems Newcastle Ltd

GB-MF-000020595

Active308 devices

Address: Balliol Business Park, NE12 8EW Newcastle Upon Tyne
Role: Manufacturer
Date of registration: Feb 21, 2022
Country: United Kingdom

Leica Biosystems Newcastle Ltd is a medical device manufacturer registered in EUDAMED. The company has 308 devices on the EU market across 31 countries. It holds 1 valid CE certificate. Headquartered in Newcastle Upon Tyne, United Kingdom. Explore the regulatory profile, devices and certificates on MD Atlas.

About Leica Biosystems Newcastle Ltd

: GB-MF-000020595
Role: Manufacturer
Country: United Kingdom
Organization name: Leica Biosystems Newcastle Ltd
EU VAT number: GB 974 9710 70
EORI: 974971070000
Date of registration: Feb 21, 2022

Contact details for Leica Biosystems Newcastle Ltd

Email: lynne.dobson@leicabiosystems.com
Website: www.leicabiosystems.com
Address: BALLIOL BUSINESS PARK BENTON LANE NE12 8EW NEWCASTLE UPON TYNE UNITED KINGDOM

Competent authority

Name: Ministerie van Volksgezondheid, Welzijn en Sport

Phone: +31 70 340 79 11
Email: medische_hulpmiddelen@minvws.nl

Officers and regulatory representatives of Leica Biosystems Newcastle Ltd

DOBSON Lynne
Ensuring the conformity of devices is checked before release in accordance with the QMS under which the devices are manufactured; Ensuring technical documentation and the EU DoC are kept up-to-date; Ensure the PMS and vigilance reporting obligations are complied with; Investigational devices contain a signed statement required of Annex XIV Section 4.1 that the device conforms to GSPRs apart from the aspects covered by the performance study
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JOOSTE Amouri
Ensuring the conformity of devices is checked before release in accordance with the QMS under which the devices are manufactured; Ensuring technical documentation and the EU DoC are kept up-to-date; Ensure the PMS and vigilance reporting obligations are complied with; Investigational devices contain a signed statement required of Annex XIV Section 4.1 that the device conforms to GSPRs apart from the aspects covered by the performance study
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Connected operators

Importers

1 EU importer places this manufacturer's devices

Data export

Export the 308 devices of Leica Biosystems Newcastle Ltd

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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
ALK (2p23) Break	ALK (2p23) Break	`KBI-10747`	`08717973348207`	1	On the market
ALK (2p23) Proximal - XL	ALK (2p23) Proximal - XL	`KBI-XL001`	`08717973349013`	1	On the market
Alpha-Methylacyl-CoA Racemase EPMU1 7 mL	Alpha-Methylacyl-CoA Racemase EPMU1 7 mL	`PA0210`	`05055331326492`	1	On the market
Anaplastic Lymphoma Kinase 5A4 7 mL	Anaplastic Lymphoma Kinase 5A4 7 mL	`PA0831`	`05055331328700`	1	On the market
Anti-Biotin Antibody	Anti-Biotin Antibody	`AR0584`	`05055331316622`	1	On the market
Anti-Fluorescein Antibody	Anti-Fluorescein Antibody	`AR0833`	`05055331316608`	1	On the market
Anti-Fluorescein Antibody	Anti-Fluorescein Antibody	`AR0222`	`05055331316639`	1	On the market
Bcl-2 bcl-2/100-D5 7 mL	Bcl-2 bcl-2/100-D5 7 mL	`PA0117`	`05055331304612`	1	On the market
Bcl-6 LN22 7 mL	Bcl-6 LN22 7 mL	`PA0204`	`05055331304483`	1	On the market
BCL2 (18q21) Break (tissue)	BCL2 (18q21) Break (tissue)	`KBI-10745`	`08717973348184`	1	On the market
BCL2 (18q21) Distal - XL	BCL2 (18q21) Distal - XL	`KBI-XL008`	`08717973349082`	1	On the market
BCL6 (3q27) Break (tissue)	BCL6 (3q27) Break (tissue)	`KBI-10730`	`08717973342854`	1	On the market
BCL6 (3q27) Proximal - XL	BCL6 (3q27) Proximal - XL	`KBI-XL009`	`08717973349099`	1	On the market
BOND Aspirating Probe Cleaning System	BOND Aspirating Probe Cleaning System	`CS9100`	`05055331311009`	1	On the market
BOND DAB Enhancer	BOND DAB Enhancer	`AR9432`	`05055331316561`	1	On the market
BOND Dewax Solution	BOND Dewax Solution	`AR9222`	`05055331316585`	1	On the market
BOND Enzyme Pretreatment Kit	BOND Enzyme Pretreatment Kit	`AR9551`	`05055331316554`	1	On the market
BOND Epitope Retrieval Solution 1	BOND Epitope Retrieval Solution 1	`AR9961`	`05055331316523`	1	On the market
BOND Epitope Retrieval Solution 2	BOND Epitope Retrieval Solution 2	`AR9640`	`05055331316530`	1	On the market
BOND FISH Kit	BOND FISH Kit	`DS9636`	`05055331326102`	1	On the market
BOND Hybridization Solution	BOND Hybridization Solution	`AR9037`	`05055331327307`	1	On the market
Bond Open Container 30 mL	Bond Open Container 30 mL	`OP309700`	`05055331305121`	1	On the market
Bond Open Container 7 mL	Bond Open Container 7 mL	`OP79193`	`05055331305114`	1	On the market
BOND Oracle HER2 IHC System	BOND Oracle HER2 IHC System	`TA9145`	`05055331301291`	1	On the market
BOND Polymer Refine Detection	BOND Polymer Refine Detection	`DS9800`	`05055331310460`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
ALK (2p23) Break	ALK (2p23) Break	`KBI-10747`	`08717973348207`	1	On the market
ALK (2p23) Proximal - XL	ALK (2p23) Proximal - XL	`KBI-XL001`	`08717973349013`	1	On the market
Alpha-Methylacyl-CoA Racemase EPMU1 7 mL	Alpha-Methylacyl-CoA Racemase EPMU1 7 mL	`PA0210`	`05055331326492`	1	On the market
Anaplastic Lymphoma Kinase 5A4 7 mL	Anaplastic Lymphoma Kinase 5A4 7 mL	`PA0831`	`05055331328700`	1	On the market
Anti-Biotin Antibody	Anti-Biotin Antibody	`AR0584`	`05055331316622`	1	On the market
Anti-Fluorescein Antibody	Anti-Fluorescein Antibody	`AR0833`	`05055331316608`	1	On the market
Anti-Fluorescein Antibody	Anti-Fluorescein Antibody	`AR0222`	`05055331316639`	1	On the market
Bcl-2 bcl-2/100-D5 7 mL	Bcl-2 bcl-2/100-D5 7 mL	`PA0117`	`05055331304612`	1	On the market
Bcl-6 LN22 7 mL	Bcl-6 LN22 7 mL	`PA0204`	`05055331304483`	1	On the market
BCL2 (18q21) Break (tissue)	BCL2 (18q21) Break (tissue)	`KBI-10745`	`08717973348184`	1	On the market
BCL2 (18q21) Distal - XL	BCL2 (18q21) Distal - XL	`KBI-XL008`	`08717973349082`	1	On the market
BCL6 (3q27) Break (tissue)	BCL6 (3q27) Break (tissue)	`KBI-10730`	`08717973342854`	1	On the market
BCL6 (3q27) Proximal - XL	BCL6 (3q27) Proximal - XL	`KBI-XL009`	`08717973349099`	1	On the market
BOND Aspirating Probe Cleaning System	BOND Aspirating Probe Cleaning System	`CS9100`	`05055331311009`	1	On the market
BOND DAB Enhancer	BOND DAB Enhancer	`AR9432`	`05055331316561`	1	On the market
BOND Dewax Solution	BOND Dewax Solution	`AR9222`	`05055331316585`	1	On the market
BOND Enzyme Pretreatment Kit	BOND Enzyme Pretreatment Kit	`AR9551`	`05055331316554`	1	On the market
BOND Epitope Retrieval Solution 1	BOND Epitope Retrieval Solution 1	`AR9961`	`05055331316523`	1	On the market
BOND Epitope Retrieval Solution 2	BOND Epitope Retrieval Solution 2	`AR9640`	`05055331316530`	1	On the market
BOND FISH Kit	BOND FISH Kit	`DS9636`	`05055331326102`	1	On the market
BOND Hybridization Solution	BOND Hybridization Solution	`AR9037`	`05055331327307`	1	On the market
Bond Open Container 30 mL	Bond Open Container 30 mL	`OP309700`	`05055331305121`	1	On the market
Bond Open Container 7 mL	Bond Open Container 7 mL	`OP79193`	`05055331305114`	1	On the market
BOND Oracle HER2 IHC System	BOND Oracle HER2 IHC System	`TA9145`	`05055331301291`	1	On the market
BOND Polymer Refine Detection	BOND Polymer Refine Detection	`DS9800`	`05055331310460`	1	On the market

Leica Biosystems Newcastle Ltd

About Leica Biosystems Newcastle Ltd

Contact details for Leica Biosystems Newcastle Ltd

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Officers and regulatory representatives of Leica Biosystems Newcastle Ltd

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About Leica Biosystems Newcastle Ltd

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Device catalog for Leica Biosystems Newcastle Ltd

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Market presence of Leica Biosystems Newcastle Ltd

Connected operators

Importers

Export the 308 devices of Leica Biosystems Newcastle Ltd

Related searches

Market presence of Leica Biosystems Newcastle Ltd

Devices by risk class

Statistics for Leica Biosystems Newcastle Ltd

Certificate health for Leica Biosystems Newcastle Ltd

Related documents

Device catalog for Leica Biosystems Newcastle Ltd

Device families (Basic UDI-DI) of Leica Biosystems Newcastle Ltd