Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011545608

FEI Number

3011545608

Entity Name

COPIOUS (CAMBODIA) INTERNATIONAL INC.

City/State/Country

Takeo, KH

Establishment Address

National Road Number 2, Km No 68, Phum Roung, Khum Lum Chang, Srok Samrong, Takeo 21356, KH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Copious (Cambodia) International Inc. (Owner Number: 10048867)

Owner / Operator Contact Address

National Road Number 2, Km No 68, Phum Roung, Khum Lum Chang, Srok Samraon, Takeo, KH-NOTA 21356, KH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Opt-Shield Air Supine NA Copioumed Chemotherapy Isolation Gown Isolation gown TBD Facemask

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	2017-12-04
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2026-03-16
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2024-09-08
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-08-04
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2018-12-03
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2022-06-16
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-10
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2022-06-16
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-09-23
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-03-25
QSO	Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs	General, Plastic Surgery	Class 2	878.4040	2025-07-14
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-07-14
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2015-03-12
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-11-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-08-21
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2022-06-16
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-08-21
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-02-19
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-03-25
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-10-24

Official Correspondent

No official correspondent registered.

US Agent Details

Claudia Wen Email: usagent.claudiawen@gmail.com Phone: (626) 5890926

Related Public Records

Same Entity

Copious (Cambodia) International Inc.

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
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011545608. Last updated year: 2026. Please use registration number 3011545608 when referencing this establishment in official correspondence.