HomeFranceOWANDY RADIOLOGY

OWANDY RADIOLOGY

France · Croissy-Beaubourg
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, 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
4listed device types
Class I 1Class II 3Class III 0
plus 10 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
5 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
10 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
6active registrations
Class 2a 3Class 2b 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 States10 registration records, 0 510(k), 0 PMA, 2 excluded
Brazil3 confirmed, 0 excluded
Canada3 confirmed, 1 excluded
Manufacturer names merged into this page: OWANDY RADIOLOGY

Company information

Country
France
City
Croissy-Beaubourg

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 listed device types

X-Ray, Tomography, Computed, Dental 1System, X-Ray, Extraoral Source, Digital 1Unit, X-Ray, Extraoral With Timer 1Camera, Surgical And Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81504799267Sensores para Raio-X DigitaisClass II
BR81024789002Sensor para Radiografia Digital Intraoral OwandyClass II
BR81024780002SENSOR PARA RADIOGRAFIA DIGITAL INTRAORALClass II
CA93646I-MAX TOUCH 3DClass II
CA93647OW-RXClass II
CA93648I-MAX TOUCHClass II

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