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Home›Korea, Republic›HUDENS BIO CO., LTD.

HUDENS BIO CO., LTD.

Korea, Republic · Gwangju
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, 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
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States1 registration records, 1 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: HUDENS BIO CO., LTD. · HUDENS BIO. CO., LTD

Company information

Country
Korea, Republic
City
Gwangju

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

12026 · K251818

FDA listed device types

Bone Grafting Material, Synthetic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251818BONTREE PLUS2026-03-06
BR10370549005KOTA PATTERNClass II
BR10370549006KOTA REFINEClass II
SAME0000002013SFDAA00002AQRAS ARTICULATOR—
SAME0000002013SFDAA00002AQRAS ARTICULATOR—

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