HomeFranceSIM&CURE

SIM&CURE

France · Montpellier Herault
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel — 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
1listed device types
Class I 0Class II 1Class III 0
plus 6 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States6 registration records, 6 510(k), 0 PMA, 2 excluded
Brazil1 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: SIM&CURE · SIM&CURE S.A.
Same-named companies — This database also contains companies with near-identical names: SIM&CURE S.A.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
France
City
Montpellier Herault

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

12019 · K190049
12020 · K202322
12022 · K212373
12023 · K222664
12024 · K242124
12025 · K253122

FDA listed device types

Software For Visualization Of Vascular Anatomy And Intravascular Devices 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253122Sim&Size2025-12-23
USK242124Sim&Size2024-12-14
USK222664Sim&Size2023-01-27
BR81464750127Sim&SizeClass II

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