HomeTaiwanZE FANG TECHNOLOGY CO., LTD.

ZE FANG TECHNOLOGY CO., LTD.

Taiwan · Taichung
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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
8listed device types
Class I 7Class II 1Class III 0
plus 8 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
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
pendingnot queried
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 States8 registration records, 1 510(k), 0 PMA, 2 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: ZE FANG TECHNOLOGY CO., LTD. · ZE FANG TECHNOLOGY CO., LTD.,

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

12022 · K202163

FDA listed device types

Spring, Orthodontic 1Instruments, Dental Hand 1Clamp, Wire, Orthodontic 1File, Pulp Canal, Endodontic 1Tube, Orthodontic 1Bracket, Metal, Orthodontic 1Wire, Orthodontic 1Implant, Endosseous, Orthodontic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK202163Mico One Orthodontic Screw2022-10-07
BR81504799264Fio Ortodôntico Mico OneClass II
BR81504799265Braquete Ortodôntico Mico OneClass II

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