Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013217742

FEI Number

3013217742

Entity Name

BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

No.10 Juncheng Road, Eastern Zone of Guangzhou Economic & Technological Development District, Guangzhou Guangdong 510760, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Bain Medical Equipment(Guangzhou) Co., Ltd. (Owner Number: 10059567)

Owner / Operator Contact Address

No.10 Juncheng Road, Eastern Zone of Guangzhou Economic & Technological Development District, Guangzhou, CN-GD 510760, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161582

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2022-12-06
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2021-10-27

Official Correspondent

Zoe Zeng

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Bain Medical Equipment(Guangzhou) 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
K915174	Jms Co., Ltd.	JMS APHERESIS NEEDLE	1993-03-02

Similar Registrations

Registration Number	Establishment Name	Location
3003895440	PT JMS BATAM	BATAM Kepulauan Riau, ID
3010413216	SIAM STERI SERVICES CO., LTD	Panthong Chon Buri, TH
3002807350	JMS SINGAPORE PTE. LTD	SINGAPORE Central Singapore, SG
3003464075	NXSTAGE MEDICAL, INC.	LAWRENCE, MA, US
9616419	SUNDER BIOMEDICAL TECH. CO., LTD.	Yunlin County, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013217742. Last updated year: 2026. Please use registration number 3013217742 when referencing this establishment in official correspondence.