encevis

FDA UDI

Class II (US FDA UDI)

by AIT Austrian Institute of Technology GmbH

Identity

Trade Name: encevis FDA UDI
Generic Name: Bioelectrical signal analysis software FDA UDI
Device Name: encevis is a quantitative EEG trending, spike, seizure and status epilepticus detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings. FDA UDI
Model / Reference: 2.1/2.2 FDA UDI
Description: encevis is a quantitative EEG trending, spike, seizure and status epilepticus detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings. FDA UDI

Identifiers

Primary DI / UDI-DI: 09120109830269 FDA UDI
510(k) Number: K240993 FDA UDI
FDA Product Code: OMB FDA UDI
OLT FDA UDI
OMA FDA UDI
GMDN Term: Bioelectrical signal analysis software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 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: Bioelectrical signal analysis software

encevis by AIT Austrian Institute of Technology GmbH — 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: AIT Austrian Institute of Technology GmbH

Sources (1)

FDA UDI b0a9b330-6fa7-4c75-a5cd-f43379a42be2 34 fields · synced Jun 8, 2026