HomeUSABioness, Inc.

Bioness, Inc.

USA · Valencia
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, Australia, Israel, Russia — 7 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
13510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
5 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 2IIa 2IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
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 States0 registration records, 13 510(k), 0 PMA, 1 excluded
Saudi Arabia3 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: BIONESS INC. · Bioness Inc.

Company information

Country
USA
City
Valencia

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

12011
22012
12013
12015
12017
12018
32019
22020
12022

Registration details (sample)

MarketIdentifierNameClass / date
USK211965StimRouter Neuromodulation System2022-02-23
USK200482StimRouter Neuromodulation System2020-03-27
USK200262L100 Go System2020-03-04
SAME0000011317SFDAA00001Vector ELITE
SAME0000011317SFDAA00002Bioness Integrated Therapy

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