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Invacare Corporation

Germany · Sanford

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, 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

2listed device types

Class I 2Class II 0Class III 0

plus 2 registration records and 131 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

6active device licences

Class II 6

13 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States2 registration records, 131 510(k), 0 PMA, 4 excluded

Brazil1 confirmed, 3 excluded

Saudi Arabia9 confirmed, 10 excluded

Canada6 confirmed, 1 excluded

Manufacturer names merged into this page: Invacare GmbH · INVACARE CORPORATION · invacare · invacare corporation

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203210	Invacare Platinum 5NXG Oxygen Concentrator	2021-04-12
US	K202379	Invacare AVIVA Storm RX Power Chair	2021-03-19
US	K200890	Invacare Perfecto2V Oxygen Concentrator	2020-08-06
BR	80626470001	CADEIRAS DE RODAS MANUAL TOP END INVACARE	Class I
SA	ME0000020351SFDAA00001	Invacare TDX SP2	—
SA	ME0000020351SFDAA00002	Invacare Storm4	—
CA	8190	INVACARE ASPIRATOR	Class II
CA	14182	INVACARE VENTURE HOME FILL COMPLETE HOME OXYGEN SYSTEM	Class II
CA	71682	MNS ALTERNATING PRESSURE MATTRESS SYSTEM	Class II

Invacare Corporation

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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