HomeFranceAXESS VISION TECHNOLOGY S.A.S

AXESS VISION TECHNOLOGY S.A.S

France · Joué-Lès-Tours
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong — 6 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
2listed device types
Class I 1Class II 1Class III 0
plus 3 registration records and 2 510(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
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 2IIa 2
HKHong KongMDACS
1valid listings
Class II 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 States3 registration records, 2 510(k), 0 PMA, 1 excluded
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: AXESS VISION TECHNOLOGY · AXESS VISION TECHNOLOGY S.A.S
Same-named companies — This database also contains companies with near-identical names: AXESS VISION TECHNOLOGY. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
France

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

12020 · K202180
12022 · K212886

FDA listed device types

Instrument, Manual, Surgical, General Use 1Bronchoscope (Flexible Or Rigid) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK212886Broncoflex Agile, Broncoflex Vortex, Screeni2022-02-16
USK202180Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 300300012020-10-22
BR81027719005Endoscópio descartável BroncoflexClass II
BR81027719006Sistema de Endoscopia - Monitor Screeni da Axess Vision TechnologyClass II

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