Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004168184

FEI Number

3004168184

Entity Name

SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD.

City/State/Country

Songjiang Shanghai, CN

Establishment Address

Bldg No. 5, 683 Wenbing Road, Xinbang, Songjiang Shanghai 201605, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD. (Owner Number: 9026663)

Owner / Operator Contact Address

Bldg No. 5, 683 Wenbing Road, Xinbang, Songjiang, CN-SH 201605, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K063334

PMA Number

N/A

All Registered Proprietary Names

GANGKAI GIKO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-03-31

Official Correspondent

Waika Chan

US Agent Details

William P Herris Business: BMM Wholesale LLC Email: wpherris@bmmwholesale.com Phone: (715) 8211535

Related Public Records

Same Entity

SHANGHAI GANGKAI PURIFYING PRODUCTS 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004168184. Last updated year: 2026. Please use registration number 3004168184 when referencing this establishment in official correspondence.