Zeto ONE Short-Term Electrode Set

FDA UDI

Class II (US FDA UDI)

by Zeto Inc

Identity

Trade Name: Zeto ONE Short-Term Electrode Set FDA UDI
Generic Name: Analytical scalp electrode, single-use FDA UDI
Device Name: The Zeto ONE Short-Term Electrode Set is a part of the Zeto ONE, which is an EEG system intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The short term electrode set contains 17 "Soft Flex" electrodes, 3 "Soft Flat" electrodes and 4 ECG Electrodes necessary to conduct a single EEG recording session, that is shorter than 90 minutes. FDA UDI
Model / Reference: ZP-200-67081 FDA UDI
Description: The Zeto ONE Short-Term Electrode Set is a part of the Zeto ONE, which is an EEG system intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The short term electrode set contains 17 "Soft Flex" electrodes, 3 "Soft Flat" electrodes and 4 ECG Electrodes necessary to conduct a single EEG recording session, that is shorter than 90 minutes. FDA UDI

Identifiers

Primary DI / UDI-DI: B675ONESTES1 FDA UDI
FDA Product Code: GXY FDA UDI
GMDN Term: Analytical scalp electrode, single-use 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Analytical scalp electrode, single-use

Zeto ONE Short-Term Electrode Set by Zeto Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Zeto Inc

Sources (1)

FDA UDI 95538f21-d0c7-4edf-b32b-bf1980c04d30 35 fields · synced May 30, 2026