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TECOMET, INC.

USA · Woburn

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 7 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

78listed device types

Class I 61Class II 17Class III 0

plus 94 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 4Class II 1

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

SASaudi ArabiaSFDA

90registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

59active ARTG entries

Class I 59

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 2

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 States94 registration records, 0 510(k), 0 PMA, 2 excluded

Brazil5 confirmed, 1 excluded

Saudi Arabia90 confirmed, 0 excluded

Manufacturer names merged into this page: TECOMET · TECOMET, INC. · Tecomet, Inc. · Tecomet Inc.

FDA listed device types

showing 8 of 78

Posterior Cervical Screw System 1Plate, Bone 1Screw, Fixation, Intraosseous 1Prosthesis, Elbow, Hemi-, Radial, Polymer 1Thoracolumbosacral Pedicle Screw System 1Orthosis, Spinal Pedicle Fixation 1Orthosis, Spondylolisthesis Spinal Fixation 1Mesh, Surgical, Metal 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80145901477	KIT INSTRUMENTAL DE ACESSO ANTERIOR DE QUADRIL TECOMET	Class I
BR	80145901833	Instrumental para Quadril Tecomet	Class I
BR	80044680465	Instrumentais Tecomet	Class II
SA	ME0000003204SFDAA00070	SELF-CENTERING BONE FORCEPS SPEED-LOCK	—
SA	ME0000003204SFDAA00062	BONE TAMP	—

TECOMET, INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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