HomeUSASIGMASTIM DOMESTIC LLC

SIGMASTIM DOMESTIC LLC

USA · Tualatin
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, Australia, Hong Kong, Israel — 6 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 2Class III 1
plus 3 registration records and 0 510(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
3active device licences
Class II 1Class III 2
8 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
8active ARTG entries
Class I 7IIb 1
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
1registrations
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 States3 registration records, 0 510(k), 0 PMA
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: SIGMASTIM DOMESTIC LLC

Company information

Country
USA
City
Tualatin

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

Device, Electroconvulsive Therapy 1Block, Bite 1Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder 1

Registration details (sample)

MarketIdentifierNameClass / date
CA61822OPTICAL MOTION SENSOR ASSEMBLYClass II
CA62576SPECTRUM WITH PHYSIOLOGICAL MONITORINGClass III
CA62578SPECTRUM WITHOUT PHYSIOLOGICAL MONITORINGClass III

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