Zeto EU Kft.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• zetoinc.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Flexset System

  2024-04-30

  Zeto, Inc.

• WR19 System

  2018-04-17

  Zeto, Inc.

GUDID#

• Silver-Flex-Soft-T - Soft Flex Electrodes - Tall

  ZETO, INC.

  2019-09-20

• Silver-Flex-Soft-S - Soft Flex Electrodes - Short

  ZETO, INC.

  2019-09-20

• Silver-Flat-Soft-S - Soft Flat Electrodes - Short

  ZETO, INC.

  2019-09-20

• Soft Flex-T - Soft Flex Electrodes - Tall

  ZETO, INC.

  2019-10-18

• Soft Flex-S - Soft Flex Electrodes - Short

  ZETO, INC.

  2019-10-18

• Soft Flex-M - Soft Flex Electrodes - Medium

  ZETO, INC.

  2019-10-18

• Soft Flat-S - Soft Flat Electrodes - Short

  ZETO, INC.

  2019-10-18

• Silver-Flex-Soft-M - Soft Flex Electrodes - Medium

  ZETO, INC.

  2019-08-15

• WR19 - EEG Headset

  ZETO, INC.

  2019-08-15

• Zeto ONE VEOG Cable Extension Set - The Zeto ONE VEOG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in 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 VEOG Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record vertical electrooculogram signals.

  ZETO, INC.

  2024-06-11

• Zeto ONE REF Cable Extension - The Zeto ONE REF Cable Extension is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in 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 REF Cable Extension is a lead wire with 2.5 mm jack connector at one end, and a snap-on connector for commonly available adhesive electrodes at the other end. The lead wire is used as a reference cable during EEG recording sessions.

  ZETO, INC.

  2024-06-11

• Zeto ONE Head Unit - The Zeto ONE Head Unit is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in 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 Head Unit component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.

  ZETO, INC.

  2024-06-11

• Zeto ONE HEOG Cable Extension Set - The Zeto ONE HEOG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in 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 HEOG Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record horizontal electrooculogram signals.

  ZETO, INC.

  2024-06-11

• Zeto ONE Electrode Set — Basic - "The Zeto ONE Electrode Set — Basic 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 electrode set contains 17 ""Soft Flex"" electrodes, 3 ""Soft Flat"" electrodes necessary to conduct a single EEG recording session."

  ZETO, INC.

  2024-06-11

• Zeto ONE EMG Cable Extension Set - The Zeto ONE EMG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in 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 EMG Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record electromyoogram signals.

  ZETO, INC.

  2024-06-11

• Zeto ONE ECG Cable Extension Set - The Zeto ONE ECG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in 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 ECG Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record electrocardiogram signals.

  ZETO, INC.

  2024-06-11

• Zeto ONE Display Unit - The Zeto ONE Display Unit (DU) is a part of the Zeto ONE, which is an EEG system intended for prescription use in 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 Display Unit is the parent device of the Flexset System, intended to:- power the Zeto ONE Head Unit.- aquire the Zeto ONE Head Unit's signals- transmit the obtained data to the Zeto Cloud Platform- display the currently detected EEG signals- control the recording process

  ZETO, INC.

  2024-06-11

• Zeto ONE AUX Cable Extension Set - The Zeto ONE AUX Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in 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 AUX Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record auxiliary signals.

  ZETO, INC.

  2024-06-11

• Zeto All-in-One Medical Grade PC - "The ""Zeto All-in-One Medical Grade PC"" is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in 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 product is intended to supplement the control of the Zeto ONE when attached to a medical cart."

  ZETO, INC.

  2024-11-20

• Zeto ONE Disinfection Container with Lid - The Zeto ONE Disinfection Container with Lid is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in 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 Disinfection Container is plastic bowl with a special geometry and a purpose built lid. It is intended to hold the Zeto ONE headset in a disinfecting liquid for reprocessing.

  ZETO, INC.

  2024-11-20

• Zeto ONE Short-Term Electrode Set - "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."

  ZETO, INC.

  2025-07-09

• Zeto ONE Long-Term Electrode Set - "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."

  ZETO, INC.

  2025-07-09

• Zeto ONE Head Unit - Small - The Zeto ONE Head Unit - Small is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 45-50 cm, not including newborns. The Head Unit - Small component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.

  ZETO, INC.

  2025-07-09

• Zeto ONE Head Unit - Regular - The Zeto ONE Head Unit - Regular is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 50-65 cm, not including newborns. The Head Unit - Regular component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.

  ZETO, INC.

  2025-07-09

• Zeto ONE Head Unit - Small - The Zeto ONE Head Unit - Small is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 45-50 cm, not including newborns. The Head Unit - Small component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.

  ZETO, INC.

  2026-03-13

• Zeto ONE Head Unit - Regular - The Zeto ONE Head Unit - Regular is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children with head circumference of approximately 50-65 cm, not including newborns. The Head Unit - Regular component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.

  ZETO, INC.

  2026-03-13

• Soft Flat-T - Soft Flat Electrodes - Tall

  ZETO, INC.

  2021-01-25

• Zeto ONE Display Unit - The Zeto ONE Display Unit (DU) is a part of the Zeto ONE system, which is an EEG system intended to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. Perscription use only.The Display Unit is the parent device of the Flexset System, intended to:power the Zeto ONE Head Unit.aquire the Zeto ONE Head Unit's signalstransmit the obtained data to the Zeto Cloud Platformdisplay the currently detected EEG signalscontrol the recording processThe Display Unit is supplied with a USB power delivery-capable charger and an appropriate type C charging cable.

  ZETO, INC.

  2025-11-19

• Dry Flex-T - Dry Flex Electrodes - Bristle Tall

  ZETO, INC.

  2021-01-25

• Dry Flex-M - Dry Flex Electrode - Bristle, Medium

  ZETO, INC.

  2021-01-25

• Dry Flat-S - Dry Flat Electrode - Short

  ZETO, INC.

  2021-01-25

• Dry Flat-S - Dry Flat Electrode - Short

  ZETO INC

  2021-01-25

• Dry Flex-M - Dry Flex Electrode - Bristle, Medium

  ZETO INC

  2021-01-25

• Dry Flex-T - Dry Flex Electrodes - Bristle Tall

  ZETO INC

  2021-01-25

• Soft Flat-T - Soft Flat Electrodes - Tall

  ZETO INC

  2021-01-25