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Home›USA›Sunrise Technologies, Inc.

Sunrise Technologies, Inc.

USA · Fremont
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 18 510(k), 4 PMA
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
1 including historic records
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.

United States1 registration records, 18 510(k), 4 PMA, 18 excluded
Brazil0 confirmed, 8 excluded
Saudi Arabia0 confirmed, 15 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: SUNRISE TECHNOLOGIES, S.A.U. · SUNRISE TECHNOLOGIES, INC.
Same-named companies — This database also contains companies with near-identical names: SUNRISE TECHNOLOGIES, S.A.U.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Fremont

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

11990
41991
41992
51993 · K933017
31994 · K942542
11996 · K962192

FDA listed device types

Instrumentation For Clinical Multiplex Test Systems 1

Registration details (sample)

MarketIdentifierNameClass / date
USK962192SUNRISE CURING LAMP1996-09-03
USK942542SLASE 210 PLUS HOLMIUM LASER SYSTEM1994-09-01
USK932997MICROPREP CAVITY PREPERATION SYSTEM1994-04-25

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