HomeUSASOMNOMED, LTD.

SOMNOMED, LTD.

USA · Plano
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 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
7listed device types
Class I 3Class II 3Class III 0unclassified 1
plus 20 registration records and 12 510(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
1active ARTG entries
Class I 1
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 States20 registration records, 12 510(k), 0 PMA, 2 excluded
Manufacturer names merged into this page: SOMNOMED INC. · SOMNOMED, LTD.

Company information

Country
USA
City
Plano

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
12008
22011
12012
12013
12014
12015
12016
12019
12024
12026

FDA listed device types

Sleep Appliances With Patient Monitoring 1Device, Anti-Snoring 1Resin, Denture, Relining, Repairing, Rebasing 1Positioner, Tooth, Preformed 1Cleanser, Denture, Over The Counter 1Tray, Impression, Preformed 1Mouthguard, Prescription 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261366Virtus2026-06-12
USK233497Rest Assure System2024-10-03
USK183443SomnoDent Avant2019-05-08

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