HomeUSAMYOTRONICS-NOROMED, INC.

MYOTRONICS-NOROMED, INC.

USA · Kent
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Russia — 3 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
6listed device types
Class I 3Class II 3Class III 0
plus 6 registration records and 7 510(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
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
3active registrations
Class 2a 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.

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 States6 registration records, 7 510(k), 0 PMA
Manufacturer names merged into this page: MYOTRONICS-NOROMED, INC.

Company information

Country
USA
City
Kent

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

21999 · K992694
12000 · K003287
12001 · K013399
12003 · K031998
12004 · K040400
12011 · K111687

FDA listed device types

Stimulator, Muscle, Powered, Dental 1Device, Muscle Monitoring 1Device, Biofeedback 1Device, Dental Sonography, For Monitoring Jaw Sounds 1Device, Jaw Tracking, For Monitoring Jaw Positions 1Articulators 1

Registration details (sample)

MarketIdentifierNameClass / date
USK111687EMG SYSTEM2011-09-29
USK040400MYO-TRODE SG DISPOSABLE ELECTRODE2004-07-20
USK031998MODEL J-5 MVO-MONITOR2003-07-24

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