HomeFranceINSTITUT GEORGES LOPEZ

INSTITUT GEORGES LOPEZ

France · Lissieu Auvergne-Rhone-Alpes
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
4listed device types
Class I 1Class II 3Class III 0
plus 9 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
4 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
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
Manufacturer names merged into this page: INSTITUT GEORGES LOPEZ · INSTITUT GEORGES LOPEZ - IGL
Same-named companies — This database also contains companies with near-identical names: INSTITUT GEORGES LOPEZ - IGL. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
France
City
Lissieu Auvergne-Rhone-Alpes

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

12021 · K211224
22022 · K221387

FDA listed device types

System And Accessories, Isolated Heart, Transport And Preservation 1Set, Perfusion, Kidney, Disposable 1System, Perfusion, Kidney 1Clamp, Line 1

Registration details (sample)

MarketIdentifierNameClass / date
USK221387BEL-GEN Cold Storage Solution2022-06-14
USK221386PERF-GEN Pulsatile Perfusion Solution2022-06-14
USK211224RM4 Control Unit2021-10-15

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