HomeFranceQuantel Medical, Inc.

Quantel Medical, Inc.

France · Cournon D'Auvergne Cedex
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
8listed device types
Class I 2Class II 5Class III 1
plus 20 registration records and 33 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class II 6
10 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class III 2
21 including historic records
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 States20 registration records, 33 510(k), 0 PMA, 2 excluded
Brazil6 confirmed, 0 excluded
Canada2 confirmed, 1 excluded
Manufacturer names merged into this page: QUANTEL MEDICAL · QUANTEL MEDICAL (1 RUE DU BOIS JOLI)
Same-named companies — This database also contains companies with near-identical names: Quantel Medical S.A.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
France
City
Cournon D'Auvergne Cedex

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

22000
52002
32003
32005
22007
22009
32010
12012
22013
12014
12017
12018
22019
12020
12021
12022
12024
12026

FDA listed device types

Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Laser, Ophthalmic 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1Powered Laser Surgical Instrument 1System, Laser, Photodynamic Therapy 1Topographer, Corneal, Ac-Powered 1Light, Examination, Medical, Battery Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251507INTEGRE LIO2026-02-06
USK232302Pocket III2024-04-26
USK220430Capsulo2022-05-12
BR80686360128COMPACT TOUCHClass II
BR80686369134C.DiagClass II
BR80686369076AXIALISClass II
CA62663AXIS IIClass III
CA85328OPHTHALMIC PHOTOCOAGULATOR LASER FAMILYClass III

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