Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015167933

FEI Number

3015167933

Entity Name

DAKEWE(SHENZHEN) MEDICAL EQUIPMENT CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

101, 201, 301, 401, 601, 701, Building 11, Biomedical Enterprise Accelerator, 6 Linhui Road, Jinsha Community,, Kengzi, Pingshan, Shenzhen, China, Shenzhen Guangdong 518118, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dakewe(Shenzhen) medical equipment Co., Ltd (Owner Number: 10059546)

Owner / Operator Contact Address

101, 201, 301, 401, 601, 701, Building 11, Biomedical Enterprise Accelerator, 6 Linhui Road, Jinsha Community,, Kengzi, Pingshan, Shenzhen, China, Shenzhen, CN-GD 518118, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Embedding Cassette C02 Embedding Cassette C01 Embedding Cassette C03 Embedding Cassette C00 DP260; DP360 Fully Automated IHC Stainer NS40; NS20 HP300 Automatic tissue processor HP300 Plus Automatic tissue processor HP-HUGO Automatic tissue processor 0300911-00 Microscope Cover Glass CG0121019 Microscope Cover Glass 6250 Cryostat Microtome CT520 Cryostat Microtome CT620 Cryostat Microtome

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KER	Container, Embedding	Pathology	Class 1	864.3010	2021-06-18
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2019-01-31
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2019-01-31
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2020-01-20
IDP	Microtome, Cryostat	Pathology	Class 1	864.3010	2019-01-31

Official Correspondent

YUHAO TANG

US Agent Details

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

Related Public Records

Same Entity

Dakewe(Shenzhen) medical equipment Co., Ltd

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
2518071	POLYSCIENCES, INC.	WARRINGTON, PA, US
3013530901	HANGZHOU ROLLMED CO.,LTD.	Hangzhou Zhejiang, CN
1055757	General Data Healthcare	Cincinnati, OH, US
3010420046	CITOTEST Labware Manufacturing CO., LTD.	Haimen Jiangsu, CN
3007480628	Jiangsu Huida Medical Instruments Co., Ltd	Yancheng Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015167933. Last updated year: 2026. Please use registration number 3015167933 when referencing this establishment in official correspondence.