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HIGHRIDGE MEDICAL BRASIL LTDA

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

112listed device types

Class I 68Class II 38Class III 4unclassified 2

plus 342 registration records and 2 510(k), 81 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

24registered devices

Class I 23Class II 1

62 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

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 States342 registration records, 2 510(k), 81 PMA

Brazil24 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Highridge Medical, LLC · HIGHRIDGE MEDICAL, LLC · HIGHRIDGE MEDICAL BRASIL LTDA

FDA 510(k) clearances by year

22025 · K253093

FDA listed device types

showing 8 of 112

Electrosurgical, Cutting & Coagulation & Accessories 1Posterior Cervical Screw System 1Intervertebral Fusion Device With Bone Graft, Thoracic 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Cerclage, Fixation 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253093	Vital Spinal Fixation System	2025-12-17
US	K250332	Virage® OCT Spinal Fixation System	2025-04-04
BR	80444810101	INSTRUMENTAL MERGENCE ANTERIOR PREPARATION	Class I
BR	80444810054	Instrumentais Polaris 4.75	Class I
BR	80444810095	Instrumentais The Tether	Class I

HIGHRIDGE MEDICAL BRASIL 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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