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Arjohuntleigh, Inc.

Sweden · Malmo

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class I 21Class II 1

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

SASaudi ArabiaSFDA

109registered imported devices

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

CACanadaMDALL

7active device licences

Class II 7

29 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

8device registrations

CLASS B 7CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

45active ARTG entries

Class I 28IIa 11IIb 2Class Im (measuring) 4

HKHong KongMDACS

12valid listings

Class II 9Class III 2Class IV 1

ILIsraelAMAR

17registrations

RURussiaRoszdravnadzor

10active registrations

Class 1 2Class 2a 6Class 2b 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 States1 registration records, 1 510(k), 0 PMA, 4 excluded

Brazil22 confirmed, 0 excluded

Saudi Arabia109 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: ARJOHUNTLEIGH AB · ArjoHuntleigh AB

Registration details (sample)

Market	Identifier	Name	Class / date
US	K110994	PARKER 500	2011-07-06
BR	81695960037	Cama Hospitalar Citadel	Class I
BR	81695960038	Equipamento de mobilização Sara Combilizer	Class I
BR	81695960039	Cadeira de Higiene Carino	Class I
SA	ME0000009224SFDAA00001	Passive Clip Sling	—
SA	ME0000009224SFDAA00002	Passive Loop Sling	—
CA	72593	ROTOPRONE	Class II
CA	27979	TRIADYNE CRITICAL CARE SYSTEM	Class II
CA	27984	LOW AIRLOSS THERAPY BEDS	Class II

Arjohuntleigh, 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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