HomeKorea, RepublicNEOBIOTECH CO., LTD.

NEOBIOTECH CO., LTD.

Korea, Republic · Wonju-Si Gangwon
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Israel, Russia — 7 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
8listed device types
Class I 5Class II 3Class III 0
plus 18 registration records and 17 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
8registered devices
Class I 4Class II 4
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
5valid device licences
Class I 2Class II 1Class III 2
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
14active ARTG entries
Class I 3IIa 8IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
9active registrations
Class 2a 4Class 2b 5
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 States18 registration records, 17 510(k), 0 PMA
Brazil8 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: NEOBIOTECH CO., LTD. · NEOBIOTECH, Co., LTD

Company information

Country
Korea, Republic
City
Wonju-Si Gangwon

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

12004
32009
42012
12017
42018
12019
12021
22024

FDA listed device types

Tray, Impression, Preformed 1Facebow 1Accessories, Implant, Dental, Endosseous 1Drill, Dental, Intraoral 1Guide, Surgical, Instrument 1Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1Screw, Fixation, Intraosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232528Protective Cap2024-04-30
USK232049IS-III active Short Implant2024-03-28
USK210903IS Multi Unit Abutment System2021-07-23
BR80724000013BRUSHClass I
BR80724009001KIT SCAClass II
BR80724009002KIT SLAClass II

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