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HOWMEDICA INTERNATIONAL S. DE R.L.

Ireland · Raheen

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, South Korea — 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

40listed device types

Class I 2Class II 37Class III 1

plus 113 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 2Class II 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

11active device licences

Class III 11

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

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 States113 registration records, 0 510(k), 0 PMA, 16 excluded

Brazil4 confirmed, 5 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada11 confirmed, 2 excluded

Manufacturer names merged into this page: HOWMEDICA INTERNATIONAL S. DE R.L., · HOWMEDICA INTERNATIONAL S DE R.L. · HOWMEDICA INTERNATIONAL S. DE R.L

FDA listed device types

showing 8 of 40

Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Cerclage, Fixation 1Screw, Fixation, Bone 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Cement Obturator 1Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80005430048	PINÇAS CONQUEST DE APRENSAO PARA CIRURGIAS ARTROSCOPICAS STRYKER	Class II
BR	80005430196	INSTRUMENTAL PARA CIRURGIA DE JOELHO	Class II
BR	80005430244	PROVA DE INSTRUMENTAL EM CROMO COBALTO PARA CIRURGIA DE JOELHO STRYKE	Class I
CA	10469	OH-HARRIS PROTUSIO SHELL	Class III
CA	10682	F.R. THOMPSON HIP ENDOPROSTHESIS SYSTEM	Class III
CA	10684	RESORBABLE INTRAMEDULLARY PLUG	Class III

HOWMEDICA INTERNATIONAL S. DE R.L.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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