ORTEC Co., LTD.

Korea, Republic · Busan

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan — 4 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

9listed device types

Class I 9Class II 0Class III 0

plus 9 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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

SASaudi ArabiaSFDA

21registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

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 States9 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia21 confirmed, 0 excluded

Manufacturer names merged into this page: ORTEC Co., LTD. · ORTEC CO., LTD. · ORTEC CO., LTD · ORTEC CO LTD · ORTEC

FDA listed device types

showing 8 of 9

Orthosis, Limb Brace 1Joint, Knee, External Brace 1Cage, Knee 1Orthosis, Lumbar 1Component, Cast 1Sling, Arm 1Splint, Extremity, Non-Inflatable, External, Non-Sterile 1Splint, Hand, And Components 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80314090022	FAMÍLIA DE ÓRTESES PARA COLUNA	Class I
BR	80314090023	FAMÍLIA DE ÓRTESES PARA MEMBRO INFERIOR	Class I
BR	80314090024	FAMÍLIA DE ÓRTESES PARA MEMBRO SUPERIOR	Class I
SA	ME0000001059SFDAA00015	Spinal Orthosis	—
SA	ME0000001035SFDAA00009	Lower Limb Orthosis Back Knee Brace	—

ORTEC Co., LTD.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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