CG BIO CO., LTD.

Korea, Republic · Hwaseong-Si Gyeonggi

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 8 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

13listed device types

Class I 7Class II 6Class III 0

plus 14 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class II 2Class III 1

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIb 1

HKHong KongMDACS

3valid listings

Class III 1Class IV 2

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 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 States14 registration records, 6 510(k), 0 PMA, 4 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: CG BIO CO., LTD. · CG BIO CO. LTD.

FDA 510(k) clearances by year

12013 · K122490

12016 · K160731

12023 · K222229

12025 · K250582

22026 · K253199

FDA listed device types

showing 8 of 13

Bandage, Liquid, Skin Protectant 1Dressing, Wound, Hydrophilic 1Bone Marrow Biopsy Tray 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Orthopedic Manual Surgical Instrument 1Elastomer, Silicone, For Scar Management 1Dressing, Wound, Occlusive 1Thoracolumbosacral Pedicle Screw System 1

Market	Identifier	Name	Class / date
US	K253199	CURASYS 2 (EMDN0003)	2026-06-23
US	K252251	EASYMADE-TI	2026-04-09
US	K250582	COLONNADE Posterior Screw Fixation System	2025-05-08

CG BIO 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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