What does Copioumed International, Inc. manufacture?

Registered with the FDA for 14 device types.

Is Copioumed International, Inc. still registered with the FDA?

Yes. The registration is current and expires 2026.

Copioumed International, Inc. → Supplier → Allomedo

Copioumed International, Inc. is a specification developer holding a current FDA establishment registration. The registration covers Cap, Surgical, Gown, Surgical and 12 other device types. 12 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 1995.

14device types registered with the FDA

12products catalogued under its own name

10510(k) clearances

Registration

FDA registration record for Copioumed International, Inc.
Registered name	COPIOUMED INTERNATIONAL, INC.
Status	Registered
Registration expires	2026
Registration number	9681151
FEI number	3003792528
DUNS	658318113
Establishment type	Specification developer, Manufacturer, Exporter

Chinese Registration

Chinese company register details for Copioumed International, Inc.
Chinese legal name	新萬盟有限公司
Source	Taiwan company register lookup

Location

Address of Copioumed International, Inc.
City	Taipei
Province	Taiwan
Address	16F-4, No.1, Fuxing North Road
Postal code	105
Country	China

What It Makes

Device types Copioumed International, Inc. is registered to make
Device type	Class	Listed under the names	Listed since	Chinese makers
Accessory, Surgical Apparel	Class 1	Multiple Labels, generic	2002	439
Cap, Surgical	Class 1	Generic	1995	178
Cover, Shoe, Operating-Room	Class 1		2008	176
Garment, Protective, For Incontinence	Class 1		2022	181
Gown, Examination	Class 1	Generic	1995	109
Gown, Isolation, Surgical	Class 2	Copioumed Chemotherapy Isolation Gown	2006	21
Gown, Surgical	Class 2		2026	68
Mask, Surgical	Class 2		2008	125
Medical Gowns With Chemotherapy Labeling Claims – Tested For Use With Chemotherapy Drugs	Class 2	Copioumed Chemotherapy Isolation Gown	2025	2
Non-Surgical Gown	Class 1		2011	318
Polymer Patient Examination Glove	Class 1		2008	83
Shoe And Shoe Cover, Conductive	Class 1	Generic	1995	32
Suit, Surgical	Class 1		2022	74
Vinyl Patient Examination Glove	Class 1		2008	72

Own-Brand Listings

Devices catalogued by Copioumed International, Inc.
Product	Code	Catalogue numbers
Copioumed	FXX	20
Copioumed	FYF	15
Copioumed	FYC	13
Copioumed	OEA	5
Copioumed	FME	2
Copioumed	FYA	1
Copioumed	PUI	1
Copioumed	FXO	1
Copioumed	EYQ	1
Copioumed	BWP	1
Copioumed	FXP	1
Copioumed	LYU	1

Clearances

10 clearances name Copioumed International, Inc. as applicant. 12 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Copioumed International, Inc. or its listings
Clearance	Decision date	Product code	Route	Held by
K251860	2026-02-26	FYA	Traditional	This company
K230135	2023-10-04	FYC	Traditional	This company
K030927	2003-04-17	LYZ	Traditional	This company
K021961	2002-07-02	LYZ	Traditional	This company
K021743	2002-06-10	LZA	Traditional	This company
K972624	1997-11-06	LYZ	Traditional	This company
K965237	1997-08-27	LYU	Traditional	This company
K971316	1997-08-27	LYZ	Traditional	This company
K960999	1996-12-30	FYC	Traditional	This company
K961342	1996-12-30	FXP	Traditional	This company
K041945	2004-08-20	LYZ	Traditional	Glormed Intl., Inc.
K031104	2003-06-10	LYZ	Traditional	Glormed Intl., Inc.
K030997	2003-05-02	LYZ	Traditional	Heyuan Hongli Industries, Inc.
K022305	2002-08-08	LYZ	Traditional	Heyuan Hongli Industries, Inc.
K021353	2002-06-06	LYZ	Traditional	Glormed Intl., Inc.
K011414	2001-06-05	LYZ	Traditional	Heyuan Hongli Industries, Inc.
K011413	2001-06-05	LYZ	Traditional	Heyuan Hongli Industries, Inc.
K011412	2001-05-31	LYZ	Traditional	Heyuan Hongli Industries, Inc.
K002340	2000-08-22	LYZ	Traditional	Glormed Intl., Inc.
K983494	1998-11-05	LYZ	Traditional	Glormed Intl., Inc.
K981360	1998-10-15	LYZ	Traditional	Glormed Intl., Inc.
K970835	1997-09-03	FXX	Traditional	Tucker & Associates

From the Company

Published by the company on its own website, not by the FDA.

Information published by Copioumed International, Inc.
Founded	1994
Employees	2,500+
Factory area	China: 57,000 m²; Cambodia: 110,000 m²
Main products	surgical gowns, scrub suits, isolating gowns, face masks, doctor and nurse caps
Certifications	FDA, ISO 9001, ISO 13485
Export markets	Global
OEM and ODM	Offered

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer	Device types
Tradewinner Ltd.	4

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Copioumed International, Inc.