g.HIamp

FDA UDI

Class II (US FDA UDI)

by g.tec medical engineering GmbH

Identity

Trade Name: g.HIamp FDA UDI
Generic Name: Multiple physiological signal amplifier FDA UDI
Device Name: The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals. FDA UDI
Model / Reference: 144-Channel Amplifier FDA UDI
Description: The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals. FDA UDI

Identifiers

Catalog Number: 7002 FDA UDI
Primary DI / UDI-DI: EBCI7002US0 FDA UDI
510(k) Number: K123255 FDA UDI
FDA Product Code: GWL FDA UDI
GMDN Term: Multiple physiological signal amplifier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1835 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple physiological signal amplifier

g.HIamp by g.tec medical engineering GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K123255 also covers:

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: g.tec medical engineering GmbH

Sources (1)

FDA UDI 1df893e0-2bcc-40a1-8af2-3b5ffadc94bd 38 fields · synced May 30, 2026