Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016615220

FEI Number

3016615220

Entity Name

PHU BAO MEDICAL CO., LTD

City/State/Country

Long An Province, VN

Establishment Address

Lot C21, D2 Road, Cau Tram Industrial Park, Long Trach Ward, Can Duoc Dist., Long An Province 850000, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PHU BAO GROUP COMPANY LIMITED (Owner Number: 10074628)

Owner / Operator Contact Address

Floor 5, CJ Building, 02Bis-4-6 Le Thanh Ton Street, Sai Gon Ward, HO CHI MINH, VN-SG 70000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Perfetta Moderate Medical Face Mark PINNAKLE MODERATE UNDERPAD DRY PAD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-05-11
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2025-05-20

Official Correspondent

NGOC LE

US Agent Details

Thanh Phong Kiem Nguyen Business: GOLUS LLC Email: hello@golus.us Phone: (470) 4189790

Related Public Records

Same Entity

PHU BAO GROUP COMPANY LIMITED

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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09

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3018382937	MID-AMERICA SAFETY CORP	Elk Grove Village, IL, US
3017598017	DURIO PPE SDN. BHD.	Johor Bahru, MY
3002813051	IRIS USA INC	Pleasant Prairie, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016615220. Last updated year: 2026. Please use registration number 3016615220 when referencing this establishment in official correspondence.