Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-FIMF000024833CR023335X2
- Basic UDI-DI Code
- B-FIMF000024833CR023335X2
- Reference
- 61288
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Neuro Event Labs Oy
Additional Description
Nelli® allows users to analyze and quantify motion and sound activity that suggest seizure behavior in adults and children. Nelli® consists of software as a Medical Device and an accessory Personal Recording Unit (PRU). The PRU captures video and audio recordings of the patient either at home or in a healthcare facility. Software processes the recordings and registers motions and sounds that indicates a seizure. Users of software are healthcare professionals. PRU is used by device installers and patient caretakers.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z121002 | NERVOUS SYSTEM MONITORING SYSTEMS |
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