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Alimed, Inc.

USA · Dedham

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Australia, Israel — 5 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

46listed device types

Class I 46Class II 0Class III 0

plus 46 registration records and 11 510(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

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

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 States46 registration records, 11 510(k), 0 PMA

Brazil0 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: ALIMED, LLC · Alimed, Inc.

FDA 510(k) clearances by year

11979

11980

41982 · K822650

11984 · K840156

11992 · K920487

31996 · K963527

FDA listed device types

showing 8 of 46

Cushion, Flotation 1Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use 1Mattress, Flotation Therapy, Non-Powered 1Splint, Hand, And Components 1Orthosis, Foot Drop 1Lift, Patient, Non-Ac-Powered 1Insoles, Medical 1Device, Transfer, Patient, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K963527	UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS	1996-10-31
US	K963528	ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)	1996-10-29
US	K963526	STRAP WEDGE	1996-10-28
SA	ME0000002848SFDAA00001	Freedom Basic Foot Orthosis (BFO)	—

Alimed, 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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