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GM Dos Reis Industria e Comercio Ltda.

Brazil · Campinas Sao Paulo

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Israel — 3 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

21listed device types

Class I 12Class II 9Class III 0

plus 31 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

87registered devices

Class I 53Class II 34

157 including historic records

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

3registrations

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 States31 registration records, 19 510(k), 0 PMA

Brazil87 confirmed, 0 excluded

Manufacturer names merged into this page: GM DOS REIS INDUSTRIA E COMERCIO LTDA

FDA 510(k) clearances by year

22019

12020

12021

22023

52024

52025

32026

FDA listed device types

showing 8 of 21

Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Plate, Fixation, Bone 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Cerclage, Fixation 1Screw, Fixation, Bone 1Condylar Plate Fixation Implant 1Fastener, Fixation, Nondegradable, Soft Tissue 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261406	Versalock Proximal Tibial Plating System	2026-07-21
US	K260390	Super Upper Limbs Versalock Plating System	2026-03-17
US	K254188	Meniscus Versaflex	2026-02-19
BR	10247700046	KIM-KIT DE INSRUMENTAL PARA MINI E MICRO FRAGMENTOS	Class I
BR	10244700015	FIXADOR EXTERNO GM	Class I
BR	10247700079	INSTRUMENTAL PARA CIRÚRGIA DO PÉ	Class I

GM Dos Reis Industria e Comercio Ltda.

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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