FDA.reportPublic FDA data

TRIUX™ neo bed

Primary DI
06430056480381
Brand
TRIUX™ neo bed
Company
Megin Oy
Model
NM25906N
Device description
Patient bed for the supine measurement position
Published
2018-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OLYMagnetoencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLYMagnetoencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430056480381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430056480381064300564803816430056480381

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Regulatory Flags#

DUNS number
538025107
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430056480275EEG Cap adaptorNM24267N2016-09-23
06430056480428Finger response padNM20928X2025-04-11
06430056480008Elekta Neuromag® TRIUXNM23900N2016-09-23
06430056480039MaxFilter™ 2.2SW24051N2025-05-23
06430056480404MEGreview™SW26241N2025-05-23
06430056480411TRIUX™ neoNM27000N2025-05-23
06430056480343HPI coil set (VectorView)NM20555XNM20555N2016-09-23
0643005648029960-channel cap (S)NM20885N2016-09-23
0643005648030560-channel cap (M)NM20884N2016-09-23
0643005648031260-channel cap (L)NM20886N2016-09-23
06430056480329124-channel cap (M)NM21302N2016-09-23
06430056480336Auditory stimulator earphones (VectorView)EL21103J2016-09-23
0643005648011432-channel EEG cap (S)NM24430NNM23905N2016-09-23
0643005648012132-channel EEG cap (M)NM24431NNM23906N2016-09-23
0643005648013832-channel EEG cap (L)NM24432NNM23907N2016-09-23
06430056480015Elekta Neuromag® TRIUXNM25000N2016-09-23
06430056480022Data analysis software 3.4SW23380N2016-09-23
06430056480046MaxFilter™ 2.2SW25613N2016-09-23
06430056480053Patient chairNM23124N2016-09-23
06430056480060Patient couch NM23125N2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06430056480039MaxFilter™ 2.2Megin OyOLY2025-05-23
06430056480404MEGreview™Megin OyOLY2025-05-23
06430056480411TRIUX™ neoMegin OyOLY2025-05-23
06430056480428Finger response padMegin OyOLY2025-04-11
B956CO0275110CTF MEGCTF MEG International Services Limited PartnershipOLY2020-12-01
06430056480374TRIUX™ neo chairMegin OyOLY2018-04-30
06430056480398TRIUX™ neoMegin OyOLY2018-04-30
06430056480367Pediatric comfort setMegin OyOLY2018-04-10
04961311926266RICOH MEGRICOH COMPANY,LTD.OLY2018-03-07
0643005648011432-channel EEG cap (S)Megin OyOLY2016-09-23
06430056480008Elekta Neuromag® TRIUXMegin OyOLY2016-09-23
06430056480015Elekta Neuromag® TRIUXMegin OyOLY2016-09-23
06430056480046MaxFilter™ 2.2Megin OyOLY2016-09-23
06430056480053Patient chairMegin OyOLY2016-09-23
06430056480060Patient couch Megin OyOLY2016-09-23
06430056480077Child insert for chairMegin OyOLY2016-09-23
06430056480084Auditory stimulator (earphones)Megin OyOLY2016-09-23
06430056480091Bilateral finger response systemMegin OyOLY2016-09-23
06430056480107Head position coil setMegin OyOLY2016-09-23
0643005648019032-channel EEG cap (S)Elekta OyOLY2016-09-23
0643005648012132-channel EEG cap (M)Megin OyOLY2016-09-23
0643005648013832-channel EEG cap (L)Megin OyOLY2016-09-23
0643005648014564-channel EEG cap (S)Megin OyOLY2016-09-23
0643005648015264-channel EEG cap (M)Megin OyOLY2016-09-23
0643005648016964-channel EEG cap (L)Megin OyOLY2016-09-23
06430056480176128-channel EEG cap (M)Megin OyOLY2016-09-23
06430056480183128-channel EEG cap (L)Megin OyOLY2016-09-23
06430056480275EEG Cap adaptorMegin OyOLY2016-09-23
06430056480282SEF electrode assemblyMegin OyOLY2016-09-23