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JOIMAX, INC.

Germany · Karlsruhe Baden-Wurttemberg

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

44listed device types

Class I 33Class II 11Class III 0

plus 46 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class I 9Class II 13

25 including historic records

SASaudi ArabiaSFDA

44registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

18valid device licences

Class I 10Class II 8

SGSingaporeHSA SMDR

11device registrations

CLASS B 8CLASS C 3

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

40active ARTG entries

Class I 29IIa 3IIb 8

HKHong KongMDACS

3valid listings

Class II 2Class III 1

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

7active registrations

Class 1 1Class 2a 6

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 States46 registration records, 7 510(k), 0 PMA

Brazil22 confirmed, 1 excluded

Saudi Arabia44 confirmed, 0 excluded

Manufacturer names merged into this page: JOIMAX GMBH · JOIMAX, INC. · JOIMAX® GMBH · Joimax GmbH · joimax® GmbH

FDA 510(k) clearances by year

12005

12015

12016

12017

12019

12020

12021

FDA listed device types

showing 8 of 44

Electrosurgical, Cutting & Coagulation & Accessories 1Thoracolumbosacral Pedicle Screw System 1Arthroscope 1Orthosis, Spondylolisthesis Spinal Fixation 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Drape, Surgical, Exempt 1Orthopedic Stereotaxic Instrument 1Lavage, Jet 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203014	EndoLIF Delta-Cage and DoubleWedge-Cage	2021-09-01
US	K192663	Joimax Intracs System	2020-07-30
US	K192680	Percusys® Plus Pedicle Screw System	2019-12-18
BR	80102513623	Sistema joimax® Vitegra®	Class I
BR	80102513375	Instrumentos Joimax	Class I
BR	80102519389	Kit de acesso descartável 2 Eco TESSYS®/iLESSYS®	Class II
SA	ME0000002741SFDAA00109	Punch	—
SA	ME0000002741SFDAA00101	iLESSYS® DELTA Access Tray	—