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OTTO BOCK HUNGÁRIA KFT.

Hungary

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

14listed device types

Class I 13Class II 1Class III 0

plus 14 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

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 States14 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: Fetzer Medical Hungaria KFT. · MAM Hungária Kft. · OTTO BOCK HUNGÁRIA KFT.

Same-named companies — This database also contains companies with near-identical names: Fetzer Medical Hungaria KFT., MAM Hungária Kft.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA listed device types

showing 8 of 14

Nipple, Lambs Feeding 1Instrument, Ligature Passing And Knot Tying 1Pump, Breast, Non-Powered 1Cannula, Surgical, General & Plastic Surgery 1Forceps, General & Plastic Surgery 1Clamp 1Scissors, General, Surgical 1Retractor 1

Market	Identifier	Name	Class / date
BR	10292010055	ÓRTESES E IMOBILIZADORES DE TRONCO	Class I
BR	10292010053	COMPONENTES E ARTIGOS PARA CONFECÇÃO DE ÓRTESES ORTOPÉDICAS EXTERNAS D	Class I

OTTO BOCK HUNGÁRIA KFT.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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