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TAE YEON MEDICAL CO., LTD

Korea, Republic · Wonju-Si Gangwon

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Israel, Russia — 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 3Class II 6Class III 0

plus 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 2Class II 12

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States5 registration records, 3 510(k), 0 PMA

Brazil14 confirmed, 0 excluded

Manufacturer names merged into this page: TAEYEON MEDICAL CO., LTD. · TAE YEON MEDICAL CO., LTD · TAE YEON MEDICAL CO. LTD

FDA 510(k) clearances by year

12007 · K063708

12021 · K202027

12022 · K212700

FDA listed device types

showing 8 of 9

Orthopedic Manual Surgical Instrument 1Spinal Channeling Instrument, Vertebroplasty 1Tamp 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Arthroscope 1Orthosis, Spondylolisthesis Spinal Fixation 1Cement, Bone, Vertebroplasty 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212700	Dyflex-II	2022-11-15
US	K202027	Balex bone Expander System	2021-02-03
US	K063708	4S SPINAL SYSTEM	2007-04-24
BR	81522539022	TYP-PCDA - KIT CÂNULA PARA CIFOPLASTIA PCD SYSTEM	Class II
BR	81522539014	BALEX - Aplicador de Cimento para Cifoplastia	Class II
BR	81522539017	KIT CÂNULA DE ACESSO PARA CIFOPLASTIA	Class II

TAE YEON MEDICAL CO., LTD

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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