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OTTOBOCK SE & CO KGAA

Germany

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 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

39listed device types

Class I 38Class II 1Class III 0

plus 41 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

15registered devices

Class I 15

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

SASaudi ArabiaSFDA

190registered 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 States41 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil15 confirmed, 2 excluded

Saudi Arabia190 confirmed, 1 excluded

Manufacturer names merged into this page: Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH · OTTOBOCK SE & CO KGAA · Ottobock SE & Co. KGaA

Same-named companies — This database also contains companies with near-identical names: Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH. Company name alone cannot separate their registrations, so the figures below may include either.

FDA listed device types

showing 8 of 39

Sling, Arm, Overhead Supported 1Orthosis, Lumbar 1Joint, Hip, External Limb Component 1Unit, Wrist, External Limb Component, Mechanical 1Hand, External Limb Component, Powered 1Splint, Hand, And Components 1Unit, Wrist, External Limb Component, Powered 1Crutch 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10292010039	FAMÍLIA DE COMPONENTES E ARTIGOS PARA CONFECÇÃO DE PRÓTESES ORTOPÉDICA	Class I
BR	10292010040	FAMÍLIA DE COMPONENTES E ARTIGOS PARA CONFECÇÃO DE PRÓTESES ORTOPÉDICA	Class I
BR	10292010066	Família de Orteses Tensoras	Class I
SA	ME0000006161SFDAA00011	Klima-ArmLiner	—
SA	ME0000006161SFDAA00009	Mulfifunction correction system joints	—

OTTOBOCK SE & CO KGAA

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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