Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680887

FEI Number

3008439903

Entity Name

Fomed Industries Inc

City/State/Country

Qian Jiang Hubei, CN

Establishment Address

20 Han Sha Road, Hou Hu District, Qian Jiang Hubei 433115, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Fomed Industries Inc. (Owner Number: 9010881)

Owner / Operator Contact Address

20 Han Sha Road, Hou Hu District, Qian Jiang, CN-NOTA 433115, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Air / Water Syringe Tips Mixing Bowl Tray,Impression,Preformed(Impression tray) Cotton Tip Applicator, Micro Applicators Face Mask NON-STERILE GUAZE SPONGE, Non Woven Sponges, ABD Pads, Tracheotomy sponges, IV Drain sponges, Cotton filled sponges, Cotton filled gauze pad Surgical Face Mask Dental Barrier and Sleeves Bouffant caps Unit, Operative Dental, Accessories (Barrier Film), Half Chair Sleeves, Headrest covers Sleeves, Tray Sleeves Surgical Gown (S, M, L, XL, XXL, XXXL); Reinforced Surgical Gown (S, M, L, XL, XXL, XXXL) Lab Coats, Lab Jackets, Protection gowns U&U Sterilization Pouch And Roll SMMS wrap,CSR wrap Bandage, Elastic, Gauze packing, Triangular bandage Bandage, Elastic Shoe covers absorbent medical fiber

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2024-08-08
KXR	Applicator, Resin	Dental	Class 1	872.3140	2024-08-08
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2016-08-16
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2012-08-29
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2013-03-27
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2008-10-07
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-04-26
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2025-06-11
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2024-08-08
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2016-08-16
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-04-19
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2024-08-08
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2018-05-23
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-05-23
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2012-06-13
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2024-08-08
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2012-08-29

Official Correspondent

ALAIN PAN

US Agent Details

Hui Hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Fomed Industries 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
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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

Similar Registrations

Registration Number	Establishment Name	Location
3032747418	HEXAMED PVT LTD	Sialkot Punjab, PK
3016798774	ASCENTCARE DENTAL PRODUCTS	Grand Haven, MI, US
2437780	CARGUS INT'L, INC.	CONGERS, NY, US
3029683441	GARNET DENTECH Corp	Daegu, KR
3008346537	CANGZHOU LANKANG MEDICAL INSTRUMENTS DEVELOPING CO., LTD.	Cangzhou Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680887. Last updated year: 2026. Please use registration number 9680887 when referencing this establishment in official correspondence.