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GAUTHIER BIOMEDICAL, INC.

USA · Grafton

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 6 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

51listed device types

Class I 28Class II 23Class III 0

plus 74 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 11

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States74 registration records, 1 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Saudi Arabia8 confirmed, 0 excluded

Manufacturer names merged into this page: GAUTHIER BIOMEDICAL, INC. · GAUTHIER BIOMEDICAL INC · Gauthier Biomedical Inc. · Gauthier Biomedical, Inc.

FDA 510(k) clearances by year

12018 · K180092

FDA listed device types

showing 8 of 51

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Rod, Fixation, Intramedullary And Accessories 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Screw, Fixation, Bone 1Neurological Stereotaxic Instrument 1Appliance, Fixation, Spinal Interlaminal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180092	Intellitorq	2018-03-08
BR	80978563778	Instrumentais Reutilizáveis Arthrex XIII	Class I
BR	80044680483	Instrumentais suporte para artroplastia	Class I
BR	80145901922	Chave Torquimétrica	Class I
SA	ME0000005219SFDAA00004	Fiber Tape Cerclage Tensioner Ratcheting Handle, Reusable	—
SA	ME0000005219SFDAA00005	TRI-FLAT QUICK CONNECT FIXED INLINE HANDLE	—

GAUTHIER BIOMEDICAL, 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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