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RAY AMERICA INC

USA · Fort Lee
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
12listed device types
Class I 5Class II 7Class III 0
plus 21 registration records and 2 510(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
0active device licences
TWTaiwanTFDA
pendingnot queried
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.

United States21 registration records, 2 510(k), 0 PMA, 82 excluded
Brazil0 confirmed, 2 excluded
Saudi Arabia0 confirmed, 6 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: RAY AMERICA INC · X-Ray America, LLC
Same-named companies — This database also contains companies with near-identical names: X-Ray America, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Fort Lee

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

11985 · K851011
11989 · K893690

FDA listed device types

showing 8 of 12
Tray, Impression, Preformed 1Accessories, Implant, Dental, Endosseous 1Assembly, Tube Housing, X-Ray, Diagnostic 1Material, Impression Tray, Resin 1Teeth, Artificial, Posterior With Metal Insert 1System, Image Processing, Radiological 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1

Registration details (sample)

MarketIdentifierNameClass / date
USK893690SUPER SPEED POTTER-BUCKY (ESO5-110 & 220)1989-07-20
USK851011HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR1985-04-10

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