HomeTaiwanBOMEI CO., LTD.

BOMEI CO., LTD.

Taiwan · Taoyuan City
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Australia, Hong Kong — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 2Class II 1Class III 0
plus 4 registration records and 2 510(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
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
1valid listings
Class III 1
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 States4 registration records, 2 510(k), 0 PMA
Manufacturer names merged into this page: BOMEI CO., LTD.

Company information

Country
Taiwan
City
Taoyuan City

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

12016 · K152297
12021 · K202278

FDA listed device types

Implant, Endosseous, Orthodontic 1Accessories, Implant, Dental, Endosseous 1Instruments, Dental Hand 1

Registration details (sample)

MarketIdentifierNameClass / date
USK202278OBS Anchorage Screw, Biokey Anchorage Screw2021-01-08
USK152297OBS Anchorage Screw2016-02-09

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