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THE HYGENIC COMPANY, LLC

USA · Akron

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel, Russia — 7 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

21listed device types

Class I 21Class II 0Class III 0

plus 26 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 13

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

SASaudi ArabiaSFDA

16registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

Class I 10

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 2

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 States26 registration records, 16 510(k), 0 PMA

Brazil13 confirmed, 0 excluded

Saudi Arabia16 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: THE HYGENIC COMPANY, LLC · The Hygenic Corporation · The Hygenic Corp.

FDA 510(k) clearances by year

11979

11985

31986

21987

11988

31990

31991

11993

11996

FDA listed device types

showing 8 of 21

Solvent, Adhesive Tape 1Exerciser, Non-Measuring 1Orthosis, Limb Brace 1Dynamometer, Nonpowered 1Bag, Ice 1Binder, Medical, Therapeutic 1Dam, Rubber 1Pack, Hot Or Cold, Reusable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K954990	DENTAL DAM	1996-01-26
US	K930764	ENDO-ICE-PULP TESTER-THERMAL	1993-05-27
US	K905418	GATES GLIDDEN DRILLS	1991-07-25
BR	80041210077	BANDAGEM ELÁSTICA ADESIVA THERABAND KINESIOLOGY TAPE	Class I
BR	80041210055	DISPOSITIVO PARA EXERCÍCIOS AQUÁTICOS AQUAFINS	Class I
BR	80041210056	DISPOSITIVO PARA EXERCÍCIOS DE OMBROS THERA-BAND	Class I
SA	ME0000000497SFDAA00022	Cramer 1050i Athletic Tape	—
SA	ME0000013908SFDAA00002	Cramer 950 Porous Athletic Tape	—
CA	27307	PARABATH THERABAND PARRAFIN BATH	Class II

THE HYGENIC COMPANY, LLC

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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