HomeTaiwanTTBIO CORPORATION

TTBIO CORPORATION

Taiwan · Taichung
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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
6listed device types
Class I 5Class II 1Class III 0
plus 11 registration records and 6 510(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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
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 States11 registration records, 6 510(k), 0 PMA
Manufacturer names merged into this page: TTBIO CORPORATION

Company information

Country
Taiwan
City
Taichung

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

12014 · K132570
12015 · K141183
12019 · K190508
12020 · K201317
12022 · K210832
12023 · K232243

FDA listed device types

Handpiece, Contra- And Right-Angle Attachment, Dental 1Handpiece, Air-Powered, Dental 1Tray, Impression, Preformed 1Mouthpiece, Saliva Ejector 1Holder, Film, X-Ray 1Scaler, Ultrasonic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232243EVO 700 series high speed handpiece2023-08-23
USK210832EVOCLEAN CLEANsert Ultrasonic Insert2022-02-02
USK201317TTBIO EVOCLEAN Ultrasonic Scaler2020-12-04

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