FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuroMotor Pen
DI: 05070002974673
·
Model: NMP-P3
·
MANUS NEURODYNAMICA LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NeuroMotor Pen
- Primary DI
- 05070002974673
- Version / Model
- NMP-P3
- Company Name
- MANUS NEURODYNAMICA LTD
- Labeler DUNS
- 211339854
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-01
- Public Version
- 1
- Public Version Date
- 2025-08-11
- Public Version Status
- New
- Public Device Record Key
- 13855fb4-0f59-41f7-94b5-0004d45db41d
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PTY | Computerized Cognitive Assessment Aid, Exempt | Neurology | 882.1470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63185 | Cognitive assessment software | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05070002974673 | GS1 | ||||
| Direct Marking | 05070002974635 | GS1 |
Customer Contacts
- Phone
- +441914661640
- [email protected]