HomeKorea, RepublicB&L Biotech Co., Ltd.

B&L Biotech Co., Ltd.

Korea, Republic · Ansan-Si
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Australia, Israel — 5 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
32listed device types
Class I 30Class II 2Class III 0
plus 33 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
7 including historic records
TWTaiwanTFDA
4valid device licences
Class I 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 2IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States33 registration records, 1 510(k), 0 PMA, 234 excluded
Brazil0 confirmed, 140 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 41 excluded
Manufacturer names merged into this page: B&L BIOTECH CO., INC · B&L BIOTECH, INC.

Company information

Country
Korea, Republic
City
Ansan-Si

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

12006 · K060347

FDA listed device types

showing 8 of 32
Preparer, Root Canal Endodontic 1Scissors, Surgical Tissue, Dental 1Pick, Massaging 1Accessories, Implant, Dental, Endosseous 1Elevator, Surgical, Dental 1Instruments, Dental Hand 1Tip, Rubber, Oral Hygiene 1Forceps, Rubber Dam Clamp 1

Registration details (sample)

MarketIdentifierNameClass / date
USK060347B&L L-BETA, MODEL WL-B12006-06-05

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