FDA.report

NeuroMotor Pen

Primary DI
05070002974673
Brand
NeuroMotor Pen
Company
MANUS NEURODYNAMICA LTD
Model
NMP-P3
Device description
The NeuroMotor Pen computerised cognitive assessment aid provides clinicians in a healthcare setting with objective measures of an individual’s cognitive function through their completion of a sequence of cognitive tasks.
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
PTYComputerized Cognitive Assessment Aid, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PTYComputerized Cognitive Assessment Aid, ExemptNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05070002974635Direct MarkingGS10
05070002974673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05070002974635050700029746355070002974635
05070002974673050700029746735070002974673

GMDN Terms

TermDefinition
Cognitive assessment softwareA software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic data. The tests are completed by the patient on an off-the-shelf computer/tablet/smartphone and test results are intended to be reviewed by a medical specialist and/or used for longitudinal analysis. It is not intended for real-time home-monitoring of dementia patients.

Sterilization Methods

Method

Contacts

PhoneEmail
+441914661640support@manusneuro.com

Regulatory Flags

DUNS number
211339854
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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