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Kls Martin GmbH + Co. KG

Germany · Freiburg

✓ Record-verifiedregistrations found in 5 markets

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

169listed device types

Class I 146Class II 23Class III 0

plus 598 registration records and 80 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

51registered devices

Class I 49Class II 2

91 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

20active device licences

Class II 16Class III 4

86 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

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 States598 registration records, 80 510(k), 0 PMA

Brazil51 confirmed, 0 excluded

Canada20 confirmed, 0 excluded

Manufacturer names merged into this page: KLS Martin SE & Co. KG · KLS MARTIN SE & CO. KG · KLS-Martin L.P. · KLS Martin Malaysia Sdn. Bhd. · KLS MARTIN L.P. · GEBRUDER MARTIN GMBH & CO. KG A COMPANY OF THE KLS MARTIN GROUP

Same-named companies — This database also contains companies with near-identical names: KLS MARTIN DO BRASIL EQUIPAMENTOS MEDICOS LTDA, KLS-Martin L.P., KLS Martin Malaysia Sdn. Bhd., KLS MARTIN MANUFACTURING, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

62004

22005

72006

32007

22008

12009

22012

12013

22014

22015

42016

32017

32018

42019

22020

42022

42023

32024

42025

22026

FDA listed device types

showing 8 of 169

Chisel, Surgical, Manual 1Knife, Nasal 1Accessories, Implant, Dental, Endosseous 1Rod, Measuring Ear 1Stripper, Surgical 1Gag, Mouth 1Chisel, Bone, Surgical 1Tamp 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253660	KLS Martin Pure Pectus System	2026-02-20
US	K254162	KLS Martin Ixos System	2026-02-20
US	K250988	KLS Martin Pure Pectus System	2025-12-11
BR	81198980022	Instrumental Articulado Cortante - TIN	Class I
BR	81198980050	SISTEMA DE RETRATORES MARTRACT® TRANSPLANTE	Class I
BR	81198980064	INSTRUMENTAL CMF AÇO	Class I
CA	76422	HAND PLATES	Class III
CA	90131	HOOK	Class II
CA	90135	WIRE PASSER	Class II

Kls Martin GmbH + Co. KG

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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