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Ossur Iceland ehf.

Iceland · Reykjavik

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, 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

26listed device types

Class I 25Class II 1Class III 0

plus 26 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

24registered devices

Class I 24

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

1active device licences

Class II 1

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

30active ARTG entries

Class I 30

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 States26 registration records, 0 510(k), 0 PMA

Brazil24 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Ossur Iceland ehf. · OSSUR ICELAND EHF · ÖSSUR ICELAND EHF

FDA listed device types

showing 8 of 26

Orthosis, Lumbar 1Hand, External Limb Component, Powered 1Splint, Hand, And Components 1Orthosis, Limb Brace 1Binder, Abdominal 1Shoe, Cast 1Hand, External Limb Component, Mechanical 1Pack, Hot Or Cold, Reusable 1

Market	Identifier	Name	Class / date
BR	81690010044	JOELHO POWER KNEE	Class I
BR	81690010041	SOLUÇÕES PROTÉTICAS i-DIGITS	Class I
BR	81690010045	AEROFIT ÖSSUR	Class I
CA	92177	POWER KNEE	Class II

Ossur Iceland ehf.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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