CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
12 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
6 including historic records
TWTaiwanTFDA
10valid device licences
Class II 5Class III 5
SGSingaporeHSA SMDR
2device registrations
CLASS D 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
20active ARTG entries
Class I 4Class III 16
HKHong KongMDACS
20valid listings
Class IV 20
ILIsraelAMAR
9registrations
RURussiaRoszdravnadzor
3active registrations
Class 3 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.