Medi-Stim

FDA UDI

Class II (US FDA UDI)

by Everyway Medical Instruments Co., Ltd.

Identity

Trade Name: MEDI-STIM FDA UDI
Generic Name: Analytical non-scalp cutaneous electrode FDA UDI
Device Name: Analytical non-scalp cutaneous electrode A non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) and connected to an appropriate parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), impedance pneumography (IP)]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small cup/disk with a conductive surface and may include a length of insulated connecting wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. FDA UDI
Model / Reference: CSK-O FDA UDI
Description: Analytical non-scalp cutaneous electrode A non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) and connected to an appropriate parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), impedance pneumography (IP)]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small cup/disk with a conductive surface and may include a length of insulated connecting wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. FDA UDI

Identifiers

Primary DI / UDI-DI: 04719871183991 FDA UDI
FDA Product Code: GXY FDA UDI
GMDN Term: Analytical non-scalp cutaneous electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Analytical non-scalp cutaneous electrode

Medi-Stim by Everyway Medical Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Alpha — WillowWood Global LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Everyway Medical Instruments Co., Ltd.

Sources (1)

FDA UDI ca580679-b0fc-42ab-a484-9c33aa6ed401 33 fields · synced May 30, 2026