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Cervello Software

FDA UDI

Class II (US FDA UDI)

by Blackrock Neuromed, Llc

Identity

Trade Name
CERVELLO SOFTWARE FDA UDI
Generic Name
Electroencephalography telemetric monitoring system FDA UDI
Device Name
Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases. FDA UDI
Model / Reference
RS-0003 FDA UDI
Description
Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases. FDA UDI

Identifiers

Catalog Number
RS-0003 FDA UDI
Primary DI / UDI-DI
00850154007086 FDA UDI
FDA Product Code
GWL FDA UDI
GWQ FDA UDI
OLV FDA UDI
GWK FDA UDI
GMDN Term
Electroencephalography telemetric monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1835 FDA UDI
882.1400 FDA UDI
882.1845 FDA UDI
Commercial Distribution
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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bioelectrical signal analysis softwareElectroencephalography telemetric monitoring system

Cervello Software by Blackrock Neuromed, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalography telemetric monitoring system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 4af18e92-78b9-4648-8e44-6de9668eadb0 35 fields · synced May 30, 2026