HomeUSARHYTHMLINK INTERNATIONAL, LLC

RHYTHMLINK INTERNATIONAL, LLC

USA · Columbia
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel — 7 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
9listed device types
Class I 2Class II 7Class III 0
plus 26 registration records and 18 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
9registered devices
Class II 9
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
4active device licences
Class II 4
23 including historic records
TWTaiwanTFDA
4valid device licences
Class II 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
6active ARTG entries
Class I 3IIa 2Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States26 registration records, 18 510(k), 0 PMA, 1 excluded
Brazil9 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: RHYTHMLINK INTERNATIONAL, LLC · RHYTHMLINK INTERNATIONAL LLC

Company information

Country
USA
City
Columbia

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

12002
12005
12006
12008
22009
22011
22012
22013
12014
12017
22019
12020
12021

FDA listed device types

showing 8 of 9
Electrode, Needle 1Cable, Electrode 1Electrode, Cutaneous 1Syringe, Piston 1Device, Nerve Conduction Velocity Measurement 1Electrode, Needle, Diagnostic Electromyograph 1Stimulator, Nerve 1Instrument, Manual, Surgical, General Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK203079MR Conditional Sticky Pad Electrode2021-02-09
USK200984Guardian Needle Electrode2020-05-27
USK191225EEG Electrode Template2019-08-05
BR80969860044Kit para Monitorização NeurofisiológicaClass II
BR80175179003Kit de Eletrodo PropepClass II
BR80969860020Eletrodos Adesivos Descartáveis RythmlinkClass II
CA82554EMG CABLEClass II
CA83186GOLD CUP ELECTRODESClass II
CA86262WEBBED EEG ELECTRODEClass II

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