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Infab Corporation

USA · Camarillo

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 9Class II 0Class III 0

plus 11 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

83registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States11 registration records, 6 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Saudi Arabia83 confirmed, 0 excluded

Manufacturer names merged into this page: INFAB, LLC. · INFAB CORP. · Infab Corporation · Infab corporation

FDA 510(k) clearances by year

11989 · K896289

51990 · K900970

FDA listed device types

showing 8 of 9

Surgeon'S Gloves 1Non-Surgical Gown 1Screen, Leaded, Operator Radiation Protector 1Radiographic Protective Glove 1Shield, Eye, Radiological 1Apron, Leaded 1Shield, Protective, Personnel 1Device, Transfer, Patient, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K900970	RADIATION PROTECTION GLASSES	1990-05-01
US	K900972	RADIATION PROTECTION GLOVES	1990-05-01
US	K901014	RADIOGRAPHIC INTENSIFYING SCREEN	1990-04-02
BR	10210410103	AVENTAL DE CHUMBO PARA PROTEÇÃO RADIOLÓGICA INFAB	Class I
SA	ME0000002789SFDAA00083	Tilted Mobile Barrier with Reach Through Curtain	—
SA	ME0000002789SFDAA00084	Technician Protection Mobile Screen	—

Infab Corporation

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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