EUDAMED update: Dec 9, 2025

Leica Biosystems Imaging, Inc.

US-MF-000020547

Active46 devices

Address: Park Center Drive, 1360 92081 Vista
Role: Manufacturer
Date of registration: Feb 21, 2022
Country: United States

Leica Biosystems Imaging, Inc. is a medical device manufacturer registered in EUDAMED. The company has 46 devices on the EU market across 31 countries. Headquartered in Vista, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Leica Biosystems Imaging, Inc.

: US-MF-000020547
Role: Manufacturer
Country: United States
Organization name: Leica Biosystems Imaging, Inc.
EU VAT number: Not applicable
Date of registration: Feb 21, 2022

Contact details for Leica Biosystems Imaging, Inc.

Phone: +1 866 478 9520
Email: LBS-Vista@Leicabiosystems.com
Website: LeicaBiosystems.com
Address: 1360, PARK CENTER DRIVE 92081 VISTA UNITED STATES

Data export

Export the 46 devices of Leica Biosystems Imaging, Inc.

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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 Imaging, Inc.

KOMPLIN April
Senior Regulatory Affairs Manager
Hidden

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
Aperio CS5 DX	Aperio CS5 DX	`23CS5DXIVD`	`00815477020655`	1	On the market
Aperio GT 180 DX	Aperio GT 180 DX	`23GT180DXIVD`	`00815477020679`	1	On the market
Aperio GT 450 DX	Aperio GT 450 DX	`23GT450DXIVD-R`	`00815477021775`	1	On the market
Aperio HALO AP	Aperio HALO AP	`23HALOAP`	`00815477020785`	1	On the market
Aperio iQC DX	Aperio iQC DX	`23iQCDXROW`	`00815477020709`	1	On the market
Aperio SAM DX	Aperio SAM DX	`23APERIOSAMSWDX1`	`00815477020754`	1	On the market
CytoVision DX	CytoVision DX	`23GSL10XBFF230DX`	`00815477020884`	1	On the market
GSL Workstation for BF	GSL Workstation for BF	`23GSLCPUBFXDX`	`00815477021003`	1	On the market
GSL Workstation for BF and Fluorescence	GSL Workstation for BF and Fluorescence	`23GSLCPUBFFDX`	`00815477020990`	1	On the market
GSL10 scan system BF	GSL10 scan system BF	`23GSL10XBFX230DX`	`00815477020891`	1	On the market
GSL120 scan system BF	GSL120 scan system BF	`23GSL120BFX230DX`	`00815477020914`	1	On the market
GSL120 scan system BF FL	GSL120 scan system BF FL	`23GSL120BFF230DX`	`00815477020907`	1	On the market
Karotyping and FISH Capture Workstations	Karotyping and FISH Capture Workstations	`23CAPUPSBFFDX`	`00815477021027`	1	On the market
Karotyping Capture Workstation	Karotyping Capture Workstation	`23CAPUPSBFXDX`	`00815477021010`	1	On the market
Karyo FISH Station with Camera (without Microscope and Lamphouse)	Karyo FISH Station with Camera (without Microscope and Lamphouse)	`23CAP003BFF230DX`	`00815477020969`	1	On the market
Karyo FISH Station with Camera (without Microscope)	Karyo FISH Station with Camera (without Microscope)	`23CAP002BFF230DX`	`00815477020952`	1	On the market
Karyo FISH Station with Microscope and CameraCamera	Karyo FISH Station with Microscope and CameraCamera	`23CAP001BFF230DX`	`00815477020938`	1	On the market
Karyo Station with Camera (without Microscope)	Karyo Station with Camera (without Microscope)	`23CAP003BFX230DX`	`00815477020945`	1	On the market
Karyo Station with Microscope and Camera	Karyo Station with Microscope and Camera	`23CAP001BFX230DX`	`00815477020921`	1	On the market
Karyotyping and FISH Review Software (incl Dongle)	Karyotyping and FISH Review Software (incl Dongle)	`23SWRBFFDX`	`00815477021041`	1	On the market
Karyotyping and FISH Review Station	Karyotyping and FISH Review Station	`23REV001BFF230DX`	`00815477020976`	1	On the market
Karyotyping Review Software (incl Dongle)	Karyotyping Review Software (incl Dongle)	`23SWRBFXDX`	`00815477021034`	1	On the market
Karyotyping Review Station	Karyotyping Review Station	`23REV001BFX230DX`	`00815477020983`	1	On the market
Leica DM 91024 AQUA	Leica DM 91024 AQUA	`232FL4930272DX`	`00815477021126`	1	On the market
Leica DM 91024 CY5 (Far Red)	Leica DM 91024 CY5 (Far Red)	`232FL4900972DX`	`00815477021133`	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
Aperio CS5 DX	Aperio CS5 DX	`23CS5DXIVD`	`00815477020655`	1	On the market
Aperio GT 180 DX	Aperio GT 180 DX	`23GT180DXIVD`	`00815477020679`	1	On the market
Aperio GT 450 DX	Aperio GT 450 DX	`23GT450DXIVD-R`	`00815477021775`	1	On the market
Aperio HALO AP	Aperio HALO AP	`23HALOAP`	`00815477020785`	1	On the market
Aperio iQC DX	Aperio iQC DX	`23iQCDXROW`	`00815477020709`	1	On the market
Aperio SAM DX	Aperio SAM DX	`23APERIOSAMSWDX1`	`00815477020754`	1	On the market
CytoVision DX	CytoVision DX	`23GSL10XBFF230DX`	`00815477020884`	1	On the market
GSL Workstation for BF	GSL Workstation for BF	`23GSLCPUBFXDX`	`00815477021003`	1	On the market
GSL Workstation for BF and Fluorescence	GSL Workstation for BF and Fluorescence	`23GSLCPUBFFDX`	`00815477020990`	1	On the market
GSL10 scan system BF	GSL10 scan system BF	`23GSL10XBFX230DX`	`00815477020891`	1	On the market
GSL120 scan system BF	GSL120 scan system BF	`23GSL120BFX230DX`	`00815477020914`	1	On the market
GSL120 scan system BF FL	GSL120 scan system BF FL	`23GSL120BFF230DX`	`00815477020907`	1	On the market
Karotyping and FISH Capture Workstations	Karotyping and FISH Capture Workstations	`23CAPUPSBFFDX`	`00815477021027`	1	On the market
Karotyping Capture Workstation	Karotyping Capture Workstation	`23CAPUPSBFXDX`	`00815477021010`	1	On the market
Karyo FISH Station with Camera (without Microscope and Lamphouse)	Karyo FISH Station with Camera (without Microscope and Lamphouse)	`23CAP003BFF230DX`	`00815477020969`	1	On the market
Karyo FISH Station with Camera (without Microscope)	Karyo FISH Station with Camera (without Microscope)	`23CAP002BFF230DX`	`00815477020952`	1	On the market
Karyo FISH Station with Microscope and CameraCamera	Karyo FISH Station with Microscope and CameraCamera	`23CAP001BFF230DX`	`00815477020938`	1	On the market
Karyo Station with Camera (without Microscope)	Karyo Station with Camera (without Microscope)	`23CAP003BFX230DX`	`00815477020945`	1	On the market
Karyo Station with Microscope and Camera	Karyo Station with Microscope and Camera	`23CAP001BFX230DX`	`00815477020921`	1	On the market
Karyotyping and FISH Review Software (incl Dongle)	Karyotyping and FISH Review Software (incl Dongle)	`23SWRBFFDX`	`00815477021041`	1	On the market
Karyotyping and FISH Review Station	Karyotyping and FISH Review Station	`23REV001BFF230DX`	`00815477020976`	1	On the market
Karyotyping Review Software (incl Dongle)	Karyotyping Review Software (incl Dongle)	`23SWRBFXDX`	`00815477021034`	1	On the market
Karyotyping Review Station	Karyotyping Review Station	`23REV001BFX230DX`	`00815477020983`	1	On the market
Leica DM 91024 AQUA	Leica DM 91024 AQUA	`232FL4930272DX`	`00815477021126`	1	On the market
Leica DM 91024 CY5 (Far Red)	Leica DM 91024 CY5 (Far Red)	`232FL4900972DX`	`00815477021133`	1	On the market

Leica Biosystems Imaging, Inc.

About Leica Biosystems Imaging, Inc.

Contact details for Leica Biosystems Imaging, Inc.

Export the 46 devices of Leica Biosystems Imaging, Inc.

Competent authority

Officers and regulatory representatives of Leica Biosystems Imaging, Inc.

Related searches

About Leica Biosystems Imaging, Inc.

Contact details for Leica Biosystems Imaging, Inc.

Export the 46 devices of Leica Biosystems Imaging, Inc.

Competent authority

Officers and regulatory representatives of Leica Biosystems Imaging, Inc.

Statistics for Leica Biosystems Imaging, Inc.

Certificate health for Leica Biosystems Imaging, Inc.

Devices by risk class

Market presence of Leica Biosystems Imaging, Inc.

Device catalog for Leica Biosystems Imaging, Inc.

Device families (Basic UDI-DI) of Leica Biosystems Imaging, Inc.

Related searches

Certificate health for Leica Biosystems Imaging, Inc.

Statistics for Leica Biosystems Imaging, Inc.

Market presence of Leica Biosystems Imaging, Inc.

Devices by risk class

Device families (Basic UDI-DI) of Leica Biosystems Imaging, Inc.

Device catalog for Leica Biosystems Imaging, Inc.