HomeFranceEURO DIFFUSION MEDICALE SAS

EURO DIFFUSION MEDICALE SAS

France · Domont · www.edm-imaging.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN FR-MF-000001850

This company has registrations in European Union, United States — 2 overseas markets. EU UDI-DI records ≥8, the first 300 verified individually. 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
≥8UDI-DI device records
Class I 8
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
0active device licences
TWTaiwanTFDA
0valid device licences
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.

European Union557 raw hits, 292 excluded, 8 confirmed. Large result set — only the first 300 verified
United States1 registration records, 0 510(k), 0 PMA, 3 excluded
Brazil0 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: EURO DIFFUSION MEDICALE

Regulatory identity

EU manufacturer SRN
FR-MF-000001850

Company information

Country
France
City
Domont
Website
www.edm-imaging.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsHematology & coagulation

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.

Business registration

Legal name
EURO DIFFUSION MEDICALE (EDM)
SIREN
340561257
Registration status
Active
Legal form
Société par actions simplifiée (SAS)
Incorporated
1987-01-14
Principal activity
Commerce de gros de produits pharmaceutiques (46.46Z)
Employee size band
50–99
Registered address
ZAC DU LYCEE 1 RUE DES BOISSELIERS 95330 DOMONT

Business registration data from INSEE Sirene, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

Transducer, Ultrasonic, Diagnostic 1

Registration details (sample)

MarketIdentifierNameClass / date
EU03701141201062GEL ECHOGRAPHIE SONECHO 5LClass I
EU03701141201079GEL ECHOGRAPHIE SONECHO FLACON 250MLClass I
EU03701141201055GEL ECHOGRAPHIE PREMIUM CUBI 5LClass I
EU03701141200324GEL ECHOGRAPHIE PREMIUM FLACON 250MLClass I

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