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The Electrode Store, Inc.

USA · Buckley

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 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

9listed device types

Class I 2Class II 7Class III 0

plus 14 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

8 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

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 States14 registration records, 6 510(k), 0 PMA, 5 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: THE ELECTRODE STORE · THE ELECTRODE STORE, INC. · The Electrode Store

FDA 510(k) clearances by year

21995 · K926094

32002 · K022197

12009 · K083758

FDA listed device types

showing 8 of 9

Electrode, Needle 1Cable, Electrode 1Electrode, Cutaneous 1Electrode, Electrocardiograph 1Electrode, Electrocardiograph, Multi-Function 1Device, Nerve Conduction Velocity Measurement 1Electrode, Needle, Diagnostic Electromyograph 1Device, Intravascular Catheter Securement 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K083758	SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS	2009-08-14
US	K022197	SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY	2002-08-13
US	K020910	SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF	2002-07-19
SA	ME0000008155SFDAA00002	Disposable (Hydrogel) Surface Electrodes	—
SA	ME0000008155SFDAA00003	Disposable Neonatal aEEG Hydrogel Electrodes	—

The Electrode Store, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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