Zeto ONE Long-Term Electrode Set

FDA UDI

Class II (US FDA UDI)

by Zeto Inc

Identity

Trade Name: Zeto ONE Long-Term Electrode Set FDA UDI
Generic Name: Analytical scalp electrode, single-use FDA UDI
Device Name: The Zeto ONE Long-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 Long-Term electrode set contains 17 "Soft Flex" electrodes, 3 "Soft Flat" electrodes and 4 ECG Electrodes necessary to conduct a single EEG recording session. FDA UDI
Model / Reference: ZP-200-67031 FDA UDI
Description: The Zeto ONE Long-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 Long-Term electrode set contains 17 "Soft Flex" electrodes, 3 "Soft Flat" electrodes and 4 ECG Electrodes necessary to conduct a single EEG recording session. FDA UDI

Identifiers

Primary DI / UDI-DI: B675ONELTES1 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 Long-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 da689f58-0694-4834-a750-e1846f136d12 35 fields · synced Jun 8, 2026