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Home›France›MAQUET S.A.S.

MAQUET S.A.S.

France · Ardon Orleans Cedex Loiret
✓ 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 4Class II 4Class III 0
plus 9 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 5
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
3 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 States9 registration records, 3 510(k), 0 PMA, 16 excluded
Brazil5 confirmed, 10 excluded
Saudi Arabia0 confirmed, 6 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: MAQUET S.A.S. · MAQUET S.A.
Same-named companies — This database also contains companies with near-identical names: Maquet S.A.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
France
City
Ardon Orleans Cedex Loiret

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

12007 · K070442
12012 · K113679
12013 · K130513

FDA listed device types

Light, Surgical, Floor Standing 1Lamp, Surgical 1Light, Surgical, Ceiling Mounted 1Light, Surgical, Accessories 1Tubing, Pressure And Accessories 1Camera, Surgical And Accessories 1Holder, Camera, Surgical 1Device, Medical Examination, Ac Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK130513VOLISTA 400; VOLISTA 6002013-05-08
USK113679LUCEA LED SURGICAL LIGHT SYSTEM2012-01-12
USK070442POWERLED SURGICAL LIGHT SYSTEM2007-03-16
BR80259110240Foco Cirúrgico Maquet EZEAClass I
BR80259110079FOCO CIRÚRGICO POWERLED IIClass I
BR80259110132Foco Cirúrgico VolistaClass I

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