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Allen Medical Systems, Inc.

USA · Bedford Heights

✓ 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

5510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 3Class II 2

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

SASaudi ArabiaSFDA

18registered 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

43active ARTG entries

Class I 43

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 States0 registration records, 5 510(k), 0 PMA, 5 excluded

Brazil5 confirmed, 1 excluded

Saudi Arabia18 confirmed, 0 excluded

Manufacturer names merged into this page: ALLEN MEDICAL SYSTEMS · ALLEN MEDICAL SYSTEMS, INC · Allen Medical Systems · ALLEN MEDICAL SYSTEMS, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K971988	ALLEN, ULTRA AND SMART SOCKETS	1997-07-11
US	K964273	DURA-BOARD ARMBOARD	1997-01-08
US	K960027	HIGH VOLUME I.V. & IRRIGATION TOWER	1996-03-12
BR	80978563685	Sistema de Distração para Quadril AR-6529S	Class II
BR	80978560120	SISTEMA DE DISTRAÇÃO DE TORNOZELO	Class II
BR	80978563708	SISTEMA DE SUSPENSÃO DE OMBRO - AR-1650S	Class I
SA	ME0000007666SFDAA00007	LegHolder, Junior, Maquet (1005.05B0)	—
SA	ME0000007666SFDAA00008	Radiolucent Spine Surgery Frame	—

Allen Medical Systems, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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