Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034204758

FEI Number

3034204758

Entity Name

PRINCIPLE & WILL BIOTECH CO., LTD.

City/State/Country

Ho Chi Minh Long An, VN

Establishment Address

Lot F,Duc Hoa lll -Viet Hoa Industrial Park, Duc Lap Ha Commune, Duc Hoa District., Ho Chi Minh Long An 82708, VN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Principle & Will Biotech Co., Ltd. (Owner Number: 10092004)

Owner / Operator Contact Address

F Zone, Duchoa Industrial Zone III - Viethoa, Duclapha District, Duchoa Town, Ho Chi Minh, VN-41 82700, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical Gown Surgical drape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-11-25
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2025-12-27

Official Correspondent

Alex Wu

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Principle & Will Biotech 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034204758. Last updated year: 2026. Please use registration number 3034204758 when referencing this establishment in official correspondence.