HomeChinaFussen Technology Co., Ltd.

Fussen Technology Co., Ltd.

China · Shenzhen Guangdong
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Israel — 8 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 0Class II 3Class III 0
plus 3 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 1Class II 2
4 including historic records
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
2device registrations
CLASS B 1CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
4active ARTG entries
Class I 1IIa 1IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
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 States3 registration records, 1 510(k), 0 PMA, 1 excluded
Brazil3 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: FUSSEN TECHNOLOGY CO., LTD · FUSSEN TECHNOLOGY CO.,LTD. · FUSSEN TECHNOLOGY CO. LTD · Fussen Technology Co Ltd

Company information

Country
China
City
Shenzhen Guangdong

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

12025 · K251842

FDA listed device types

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1System, X-Ray, Extraoral Source, Digital 1X-Ray, Tomography, Computed, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251842Dental Computed Tomography X-ray System2025-11-13
BR81778819087Sistema de scanner intraoral digitalClass II
BR81778819088Sistema de Placas de Imagem Intraoral DigitalClass II
BR80328810086SCANNER INTRAORAL IOS - DENTALINKClass I
SAME0000005581SFDAA00001FUSSEN Digital Intra Oral Imaging Plate System Scanner

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