Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018258446

FEI Number

3018258446

Entity Name

Daichuan Medical (Shenzhen) Co., Ltd

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Section 401A2, 506, Building 1, Shenzhen Biomedical Innovation Industrial Park, No. 14, Jinhui Road,, Kengzi street, Pingshan District,Shenzhen, China., Shenzhen Guangdong 518100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Daichuan Medical (Shenzhen) Co., Ltd (Owner Number: 10081773)

Owner / Operator Contact Address

Section 401A2, 506, Building 1, Shenzhen Biomedical Innovation Industrial Park, No. 14, Jinhui Road,, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192704

PMA Number

N/A

All Registered Proprietary Names

Disposable GI Endoscope, XZING-W200B Disposable Colonoscope, XZING-C200B Camera System, XZING-S2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-05-14
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-05-14

Official Correspondent

Iris Wang

US Agent Details

Tingni Tang Email: wm1101046097_k@163.com Phone: (346) 6252263

Related Public Records

Same Entity

Daichuan Medical (Shenzhen) 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
K232314	FUJIFILM Healthcare Americas Corporation	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	2023-09-01

Similar Registrations

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3006161756	FUJIFILM Healthcare Manufacturing Corporation Sano Office	Sano City Tochigi, JP
3004837686	Micro-Tech (Nanjing) Co., Ltd.	NAN JING Jiangsu, CN
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US
3015136743	STERI-TECH CO.,LTD.	KAZO-SHI Saitama, JP
3008797804	ALTON SHANGHAI MEDICAL INSTRUMENTS CO LTD	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018258446. Last updated year: 2026. Please use registration number 3018258446 when referencing this establishment in official correspondence.