cognitrace

GUDID B195LC107

cognitrace component

eemagine Medical Imaging Solutions GmbH

Electroencephalographic monitoring system, stationary
Primary Device IDB195LC107
NIH Device Record Key38c9351c-b36a-4200-b1d9-0dacb55f568a
Commercial Distribution StatusIn Commercial Distribution
Brand Namecognitrace
Version Model NumberLC-107
Company DUNS313152485
Company Nameeemagine Medical Imaging Solutions GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+493029048404
Emailsupport@eemagine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB195LC107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-08
Device Publish Date2020-04-30

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