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Medartis, Inc.

USA · Basle

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, South Korea, Australia, Hong Kong — 8 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

48listed device types

Class I 32Class II 15Class III 1

plus 128 registration records and 47 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 6Class II 4

41 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

7device registrations

CLASS C 7

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

32active ARTG entries

Class I 11IIa 8IIb 13

HKHong KongMDACS

7valid listings

Class II 1Class III 6

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 States128 registration records, 47 510(k), 0 PMA, 1 excluded

Brazil10 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: Medartis Inc. · MEDARTIS AG · Medartis AG

FDA 510(k) clearances by year

31999

42005

12007

42009

12010

42011

22012

12013

12014

22015

22017

22018

32019

52020

52023

32024

12025

32026

FDA listed device types

showing 8 of 48

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Rod, Fixation, Intramedullary And Accessories 1Staple, Fixation, Bone 1Plate, Bone 1Thoracolumbosacral Pedicle Screw System 1Pin, Fixation, Smooth 1External Mandibular Fixator And/Or Distractor 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260761	APTUS Clavicle System 2.8	2026-06-05
US	K260934	TITAN Nail; APTUS K-Wire System	2026-04-17
US	K253916	APTUS Shoulder Proximal Humerus System, PentaLock 3.5	2026-03-16
BR	80051730004	KIT INSTRUMENTAL PARA SISTEMA DE PLACAS PARAFUSOS E TELAS PARA CIRURGI	Class I
BR	80051730006	KIT INSTRUMENTAL DE PLACAS PARAFUSOS E TELAS PARA CIRURGIA BUCOMAXILO	Class I
BR	80051730007	KIT INSTRUMENTAL PARA SISTEMA DE PLACAS PARAFUSOS E TELAS PARA CIRURGI	Class I
SA	ME0000000535SFDAA00448	Case APTUS	—

Medartis, Inc.

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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