COPIOUMED INTERNATIONAL, INC.

FDA Device Registration & Listing · TAIPEI Taiwan, CN · Registration 9681151

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9681151
FEI Number
3003792528
Entity Name
COPIOUMED INTERNATIONAL, INC.
City/State/Country
TAIPEI Taiwan, CN
Establishment Address
16F-4, No.1, Fuxing North Road, Songshan District, TAIPEI Taiwan 105, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
COPIOUMED INTL., INC. (Owner Number: 9019875)
Owner / Operator Contact Address
16F-4, No.1, Fuxing North Road, Songshan District, TAIPEI, TW-TPE 105, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K983494
PMA Number
N/A

All Registered Proprietary Names

MULTIPLE LABELS Copioumed Chemotherapy Isolation Gown GENERIC GENERIC generic

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2012-01-02
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2002-04-30
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2008-01-28
FXO Suit, Surgical General, Plastic Surgery Class 1 878.4040 2022-06-16
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2012-01-02
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2008-01-28
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
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2012-01-02
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2008-01-28
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2008-01-28
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2012-01-02
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2012-01-02
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2026-03-16
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2012-01-02
BWP Shoe And Shoe Cover, Conductive General, Plastic Surgery Class 1 878.4040 1995-04-18
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2008-01-28
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 1995-04-18
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2011-04-28
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2012-01-02
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2006-02-17
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2022-06-16
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2008-01-28
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2008-01-28
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2012-01-02

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

COPIOUMED INTL., 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
K052612 Shanghai Antares Industries, Inc. DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR 2005-11-22
K120584 Wealth on (Jiangsu) Co., Ltd. POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES 2012-07-10
K220992 Ever Global (Vietnam) Enterprise Corporation Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple 2022-10-19
K112610 Inpro Technology Device Factory SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) 2011-12-05
K131340 Made Plastic Co., Ltd. POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES 2014-09-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681151. Last updated year: 2026. Please use registration number 9681151 when referencing this establishment in official correspondence.
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