HomeKorea, RepublicCORENTEC CO., LTD.

CORENTEC CO., LTD.

Korea, Republic · Cheonan Si Chungnam
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Taiwan — 3 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
55listed device types
Class I 41Class II 14Class III 0
plus 74 registration records and 33 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
4 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
7valid device licences
Class I 1Class II 6
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 States74 registration records, 33 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: CORENTEC CO., LTD.

Company information

Country
Korea, Republic
City
Cheonan Si Chungnam

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12010
22011
52012
22013
22015
32016
32017
22019
32020
22021
32022
22023
22024
12025

FDA listed device types

showing 8 of 55
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Orthosis, Spondylolisthesis Spinal Fixation 1Intervertebral Fusion Device With Bone Graft, Cervical 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250889EXULT Knee Replacement System2025-04-17
USK242401EXULT Knee Replacement System2024-09-12
USK242046EXULT Knee Replacement System2024-08-01
BR82427260001EXULT Knee System InstrumentClass I

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