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Fomed Industries, Inc.

China · Qian Jiang Hubei

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Australia, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

19listed device types

Class I 14Class II 5Class III 0

plus 18 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States18 registration records, 2 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: Fomed Industries Inc · Fomed Industries Inc.

FDA 510(k) clearances by year

12022 · K220512

12025 · K250735

FDA listed device types

showing 8 of 19

Cap, Surgical 1Applicator, Resin 1Unit, Operative Dental, Accessories 1Tray, Impression, Preformed 1Accessories, Retractor, Dental 1Cotton, Roll 1Non-Surgical Gown 1Mask, Scavenging 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250735	Dental Barrier and Sleeves	2025-06-10
US	K220512	Disposable Surgical Face Mask (M01, M02)	2022-04-25
SA	ME0000009482SFDAA00001	Ready-Pad Gauze Swabs	—

Fomed Industries, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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