COPIOUS INTL., INC.

FDA Device Registration & Listing · HEYUAN, GUANGDONG PROVINCE, CN · Registration 9614306

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
9614306
FEI Number
3003753496
Entity Name
COPIOUS INTL., INC.
City/State/Country
HEYUAN, GUANGDONG PROVINCE, CN
Establishment Address
WEI 11TH ROAD, HUADA ST., NEW CITY AREA, HEYUAN, GUANGDONG PROVINCE --, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
COPIOUS INTL., INC. (Owner Number: 9029248)
Owner / Operator Contact Address
WEI 11TH ROAD, HUADA ST., NEW CITY AREA, HEYUAN, CN-GD 517000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NA Barrier EasyWarm Active Self-Warming Blanket Multiple MULLTIPLE

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 2008-01-18
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2008-01-18
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2008-01-18
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2008-01-18
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2008-01-18
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2018-12-03
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2024-06-25
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 2008-01-18
FME Gown, Examination General Hospital Class 1 880.6265 2021-11-18
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2008-01-18
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2008-01-18
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2008-01-18
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2026-03-17
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2008-01-18
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2008-01-18
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2008-01-18

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 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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2010 Cincinnati Sub-Zero Products Inc 2
WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

Similar Registrations

Registration Number Establishment Name Location
3020106122 BINH AN MEDICAL CO., LTD Dong Trieu Township, Quang Ninh, VN
3017940518 STAR INVESTMENT AND TRADE JOINT STOCK COMPANY Bac Ninh, VN
3012304513 JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD. Dongtai Jiangsu, CN
3012317628 ZIBO LING YUN MEDICAL PRODUCTS CO., LTD. Zibo Shandong, CN
3015477649 SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD HEZE CITY Shandong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614306. Last updated year: 2026. Please use registration number 9614306 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.