HomeFrancePRODIMED SAS

PRODIMED SAS

France · Le Plessis Bouchard
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, 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
5listed device types
Class I 0Class II 5Class III 0
plus 5 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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 II 1
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
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 States5 registration records, 1 510(k), 0 PMA, 1 excluded
Brazil2 confirmed, 0 excluded
Canada1 confirmed, 1 excluded
Manufacturer names merged into this page: PRODIMED · PRODIMED SAS

Company information

Country
France
City
Le Plessis Bouchard

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

11999 · K983713

FDA listed device types

Needle, Assisted Reproduction 1Catheter, Assisted Reproduction 1Cap, Cervical 1Curette, Suction, Endometrial (And Accessories) 1Insufflator, Hysteroscopic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK983713PRODIMED MICROINJECTION PIPETTES1999-06-08
BR81375030009Conjunto de Cateter Arterial Seldicath PTFEClass II
BR81375030008Conjunto de Cateter Arterial Seldicath® PUClass II
CA67551COMBICATH BRONCHIAL LAVAGE CATHETERClass II

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