Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010461097

FEI Number

3010461097

Entity Name

Wuhan Landing Intelligence Medical Co.,Ltd

City/State/Country

Wuhan Hubei, CN

Establishment Address

Building No. B7, Medical Equipment Park, 818 Gaoxin Road, Wuhan Hubei 430206, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wuhan Landing Intelligence Medical Co.,Ltd (Owner Number: 10044976)

Owner / Operator Contact Address

Building No. B7, Medical Equipment Park, 818 Gaoxin Road, Wuhan, CN-HB 430206, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Slide Preparation Machine Automatic Liquid-Based Cytology Slide Preparation and Staining Machine Staining Machine Thionine staining solution DNA ploidy staining solution Hematoxylin staining Solution Staining Material Cytology and Histology Image Processing Software, Model: LD CytoBrain Cell Preservation Solution Cleaning Liquid Papanicolaou Staining Solution Automatic Digital Remote Pathological Cell Analyzer Microscopic Image Scanner, Model: LD Patho 320A, LD Patho 340A, LD Patho 340C Digital Slide Image Scanner, Model: LD Cyto1004, LD Cyto2200 DNA Image Cytometer, Model: LD DNA-1 Bluing Solution SmartWrite Slide Printer Sample Preservation Solution Liquid Based Cervical Cytology Kit Tissue Fixative Digital Slide Image Scanner Software Microscopic Image Scanner Software

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IFB	Cytocentrifuge	Pathology	Class 1	864.3300	2013-09-04
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2026-06-12
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2023-09-12
ICT	Azan Counterstain	Hematology	Class 1	864.1850	2013-09-04
OKY	Cytology Kit	Obstetrics/Gynecology	Class 2	884.4530	2026-06-12
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2013-09-04
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2025-02-19
HZJ	Stain, Papanicolau	Hematology	Class 1	864.1850	2021-12-14
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2014-04-14
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2023-09-12
LEA	Preservative, Cytological	Pathology	Class 1	864.4010	2026-06-11
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2020-01-18
KIP	Formulations, Balanced Salt Solutions	Hematology	Class 1	864.2875	2021-12-14
OHL	Pap Smear Kit	Obstetrics/Gynecology	Class 2	884.4530	2026-06-11
LDY	Fixative, Formalin-Containing	Pathology	Class 1	864.4010	2021-12-14
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2023-09-20

Official Correspondent

XiaoRong Sun

US Agent Details

Sandra Jiang Business: WINNING MEDCIAL GROUP INC Email: yuan.jiang363@gmail.com Phone: (863) 3233636

Related Public Records

Same Entity

Wuhan Landing Intelligence Medical Co.,Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K761138	Zeus Scientific, Inc.	FA TISSUE FIXATIVE & WASH SET	1978-01-06
K842913	E K Ind., Inc.	WRIGHT STAIN FIXATIVE	1984-09-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2020	Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands	1	V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0012-2015	Richard-Allan Scientific Company	1	Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0013-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Similar Registrations

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1063851	MERCEDES MEDICAL LLC	Lakewood Ranch, FL, US
1000303355	SAKURA SEIKI CO., LTD.	CHIKUMA-CITY Nagano, JP
3038188821	UNI MEDITREK PRIVATE LIMITED	Ghaziabad Uttar Pradesh, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010461097. Last updated year: 2026. Please use registration number 3010461097 when referencing this establishment in official correspondence.