Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010478

FEI Number

3002179321

Entity Name

LEICA BIOSYSTEMS NUSSLOCH GMBH

City/State/Country

NUSSLOCH Baden-Wurttemberg, DE

Establishment Address

HEIDELBERGER STR. 17-19, NUSSLOCH Baden-Wurttemberg 69222, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Leica Biosystems, division of Leica Microsystems, Inc. (Owner Number: 10054155)

Owner / Operator Contact Address

21440 W. Lake Cook Road, Floor 5, Deer Park, IL 60010, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HI1210 HistoCore Water Bath M CM1520 CM1860 CM1100 CM1950 CM3050 S CM1860UV HistoCore Arcadia C HistoCore Arcadia H Low-Profile Disposable Blades DB80LS (10x50) Low-Profile Disposable Blades 819 (1x50) Low-Profile Disposable Blades DB80LX (10x50) Low-Profile Disposable Blades DB80LX (1x50) High-Profile Disposable Blades DB80HS (10x50) High-Profile Disposable Blades 818 Low-Profile Disposable Blades DB80LS (1x50) High-Profile Disposable Blades 818 (10x50) High-Profile Disposable Blades DB80HS (1x50) Low-Profile Disposable Blades 819 (10x50) Coated Low Profile Microtome Blades High Profile Thin Microtome Blades Triple Facet/Low Profile/Microtome Blades High Profile Thick Microtome Blades Coated High Profile Microtome Blades ASP300S HistoCore PEARL TP1020 PELORIS Leica PELORIS II HistoCore PELORIS 3 ASP200S ASP6025 ASP6025 S HistoCore PEGASUS HistoCore PEGASUS Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IDY	Bath, Flotation, Tissue	Pathology	Class 1	864.3010	2017-04-26
IDP	Microtome, Cryostat	Pathology	Class 1	864.3010	2017-04-24
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2017-04-26
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2017-02-17
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2017-02-23

Official Correspondent

Adam Blunier

US Agent Details

Adam Blunier Business: Leica Biosystems, division of Leica Microsystems, Inc. Email: Adam.Blunier@leicabiosystems.com Phone: (630) 6340069

Related Public Records

Same Entity

Leica Biosystems, division of Leica Microsystems, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006791373	Leica Biosystems Imaging, Inc.	Vista, CA, US
8020030	LEICA BIOSYSTEMS MELBOURNE PTY LTD	MELBOURNE Victoria, AU
3004859032	LEICA BIOSYSTEMS NEWCASTLE LTD	NEWCASTLE UPON TYNE, GB
3006610913	LEICA MICROSYSTEMS LTD SHANGHAI	China (Shanghai) Pilot Free Trade Zone, CN
1419341	Leica Biosystems Richmond, Inc.	Richmond, IL, US

Similar Registrations

Registration Number	Establishment Name	Location
3006610913	LEICA MICROSYSTEMS LTD SHANGHAI	China (Shanghai) Pilot Free Trade Zone, CN
3010889707	MEDIMEAS INSTRUMENTS	Ambala Cantt Haryana, IN
3003639866	RUSHABH INSTRUMENTS, LLC	Ivyland, PA, US
3014498538	JINHUA CRAFTEK INSTRUMENT CO., LTD	Jinhua Zhejiang, CN
3016764932	ZHEJIANG GENE SCIENCE CO., LTD	shaoxing Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010478. Last updated year: 2026. Please use registration number 8010478 when referencing this establishment in official correspondence.