Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006610913

FEI Number

3006610913

Entity Name

LEICA MICROSYSTEMS LTD SHANGHAI

City/State/Country

China (Shanghai) Pilot Free Trade Zone, CN

Establishment Address

Floor 1, 2, 3A, 4A, and 6, Building T20-1 & Room 301, Building T20-5, 258 Jinzang Road, China (Shanghai) Pilot Free Trade Zone 201206, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),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 ASP300S HistoCore PEARL TP1020 PELORIS Leica PELORIS II HistoCore PELORIS 3 ASP200S ASP6025 ASP6025 S HistoCore PEGASUS HistoCore PEGASUS Plus SM2010 R DMi1 DM3000 DM2000 DM2000 LED DM1000 DM3000 LED DM1000 LED DM2500 DMi1 DM2500 DM2000 DM3000 LED DM1000 LED DM3000 DM2500LED DM1000 DM2000 LED RM2265 RM2235 RM2245 RM2255 HistoCore BIOCUT RM2125 RTS HistoCore AUTOCUT HistoCore MULTICUT HistoCore NANOCUT

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
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2017-02-23
KFL	Microtome, Sliding	Pathology	Class 1	864.3010	2017-04-26
IBK	Microscope, Fluorescence/U.V.	Pathology	Class 1	864.3600	2017-05-09
IBL	Microscope, Inverted Stage, Tissue Culture	Pathology	Class 1	864.3600	2017-05-09
IBJ	Light, Microscope	Pathology	Class 1	864.3600	2017-05-09
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	2017-04-26

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
8010478	LEICA BIOSYSTEMS NUSSLOCH GMBH	NUSSLOCH Baden-Wurttemberg, DE
3004859032	LEICA BIOSYSTEMS NEWCASTLE LTD	NEWCASTLE UPON TYNE, GB
1419341	Leica Biosystems Richmond, Inc.	Richmond, IL, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2012	Richard-Allan Scientific Company	1	Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

Similar Registrations

Registration Number	Establishment Name	Location
3010889707	MEDIMEAS INSTRUMENTS	Ambala Cantt Haryana, IN
3003639866	RUSHABH INSTRUMENTS, LLC	Ivyland, PA, US
8010478	LEICA BIOSYSTEMS NUSSLOCH GMBH	NUSSLOCH Baden-Wurttemberg, DE
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 3006610913. Last updated year: 2026. Please use registration number 3006610913 when referencing this establishment in official correspondence.