Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017170972

FEI Number

3017170972

Entity Name

SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room702.703,Building No.1 Shenzhen Biomedicine Innovations Industrial Park No.14 Jinhui Road,Kengzi Street, Shenzhen Guangdong 518122, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Dakewe Bio-engineering Co., LTD. (Owner Number: 10074984)

Owner / Operator Contact Address

Room 702.703 Building No.1Shenzhen Biomedicine Innovations Industrial Park No.14 Jinhui Road, Kengzi Street, Shenzhen, CN-GD 518122, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SNT Biotech Sterile Normal Saline Sterile Normal Saline Sterile Phosphate Buffered Saline Immunochromogenic Reagent Ki-67 Antibody Reagent Nucleic Acid Extraction Reagent(100T/Kit,500T/Kit,96T/Kit,16T/Kit) BioSciHematoxylin Staining Solution Hematoxylin Staining Solution, I Wash Solution Probe Cleaning Solution Antigen Solution Retrieval Dewax Solution Eosin Staining Solution, Water-soluble BioSciEosin Staining Solution Mounting Medium, NB-30

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2020-08-03
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2024-11-20
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2020-11-16
HYJ	Hematoxylin	Hematology	Class 1	864.1850	2023-09-07
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2024-11-20
HYB	Eosin Y	Hematology	Class 1	864.1850	2023-09-07
LEB	Mounting Media	Pathology	Class 1	864.4010	2021-06-15

Official Correspondent

Wei Jiang

US Agent Details

Leiyi Zhu Business: BioSci Inc. Email: zhu_leiyi@dakewe.com Phone: (916) 7760136

Related Public Records

Same Entity

Shenzhen Dakewe Bio-engineering 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
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017170972. Last updated year: 2026. Please use registration number 3017170972 when referencing this establishment in official correspondence.