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g.USBamp

FDA UDI

Class II (US FDA UDI)

by g.tec medical engineering GmbH

Identity

Trade Name
g.USBamp FDA UDI
Generic Name
Multiple physiological signal amplifier FDA UDI
Device Name
The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for the EEG. FDA UDI
Model / Reference
USB Biosignal Amplifier FDA UDI
Description
The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for the EEG. FDA UDI

Identifiers

Catalog Number
0216 FDA UDI
Primary DI / UDI-DI
EBCI02160 FDA UDI
510(k) Number
K060803 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
g.tec medical engineering GmbH

Sources (1)

  • FDA UDI 8a212b19-e965-47bf-9ae2-c58481dca095 39 fields · synced Jun 8, 2026