HomeSwitzerlandSWISSRAY Medical, AG

SWISSRAY Medical, AG

Switzerland · Hochdorf
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Russia — 4 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 4 registration records and 4 510(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
2active device licences
Class II 2
10 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2b 2
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 States4 registration records, 4 510(k), 0 PMA, 3 excluded
Canada2 confirmed, 1 excluded
Manufacturer names merged into this page: SWISSRAY Medical, AG · SWISSRAY MEDICAL AG

Company information

Country
Switzerland
City
Hochdorf

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

12005 · K052943
12011 · K110828
12012 · K123005
12013 · K131314

FDA listed device types

System, X-Ray, Stationary 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1

Registration details (sample)

MarketIdentifierNameClass / date
USK131314DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)2013-06-25
USK123005DDRVERSA MOTION2012-12-07
USK110828DDRELEMENT2011-08-23
CA65208DDRCOMBIClass II
CA76582DDR COMPACT SERIES X-RAY DIGITAL MULTI FUNCTION SYSTEMSClass II

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