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Joerns Healthcare, Inc.

USA · Arlington

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Canada, Australia — 4 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

11listed device types

Class I 7Class II 4Class III 0

plus 30 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

9registered imported devices

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

CACanadaMDALL

7active device licences

Class II 7

41 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 3IIa 1

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 States30 registration records, 2 510(k), 0 PMA

Saudi Arabia9 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: Joerns Healthcare Brownsville · Joerns Healthcare · Joerns Healthcare Matamoros · JOERNS HEALTHCARE · JOERNS HEALTHCARE INC. · Joerns Healthcare Ltd

FDA 510(k) clearances by year

11995 · K951735

11997 · K964926

FDA listed device types

showing 8 of 11

Protector, Skin Pressure 1Orthosis, Truncal/Orthosis, Limb 1Cover, Mattress (Medical Purposes) 1Mattress, Flotation Therapy, Non-Powered 1Chair, Posture, For Cardiac And Pulmonary Treatment 1Lift, Patient, Non-Ac-Powered 1Bed, Manual 1Bed, Ac-Powered Adjustable Hospital 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K964926	BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC	1997-11-03
US	K951735	JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL	1995-08-18
SA	ME0000001383SFDAA00003	Oxford Presence	—
SA	ME0000001383SFDAA00001	Dolphin Fluid Immersion Simulation	—
CA	73511	ARISE TURNING LOW AIR LOSS SYSTEM	Class II
CA	73512	ARISE ALTERNATING PRESSURE RELIEF SYSTEM	Class II
CA	87611	DERMAFLOAT LR SYSTEM	Class II

Joerns Healthcare, 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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