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HEXACATH

France · Rueil-Malmaison
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Hong Kong, Israel, Russia — 7 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
3listed device types
Class I 0Class II 3Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
1active device licences
Class IV 1
5 including historic records
TWTaiwanTFDA
7valid device licences
Class II 5Class III 2
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
3active registrations
Class 3 3
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 States1 registration records, 1 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: HEXACATH

Company information

Country
France
City
Rueil-Malmaison

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

12023 · K222023

FDA listed device types

Catheter, Intravascular, Diagnostic 1Catheter, Continuous Flush 1Catheter, Percutaneous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK222023RayFlow2023-04-06
CA70498HELISTENT TITAN 2 WITH DELIVERYClass IV

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