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Arjohuntleigh Polska SP Z.O.O.

United Kingdom of Great Britain and Northern Ireland · Cardiff

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

23listed device types

Class I 15Class II 8Class III 0

plus 35 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States35 registration records, 2 510(k), 0 PMA, 4 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ArjoHuntleigh Polska Sp. zo.o.

FDA 510(k) clearances by year

12012 · K122330

12014 · K133119

FDA listed device types

showing 8 of 23

Bed, Patient Rotation, Powered 1Sleeve, Limb, Compressible 1Stretcher, Wheeled 1Bath, Hydro-Massage 1Bed, Ac-Powered Adjustable Hospital 1Bed, Air Fluidized 1Mattress, Air Flotation, Alternating Pressure 1Bed, Flotation Therapy, Powered 1

Market	Identifier	Name	Class / date
US	K133119	FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS	2014-02-28
US	K122330	FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE	2012-12-07

Arjohuntleigh Polska SP Z.O.O.

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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