Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 00628942046230
- Basic UDI-DI Code
- B-00628942046230
- Reference
- ND-1-204
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Nuraleve
Additional Description
The SmartStim Model 1000 device is intended to apply established standard transcranial direct current stimulation treatment protocols, with the device being operated by a trained professional. tDCS is a non-invasive neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. It is indicated for the treatment of disorders requiring neuromodulation, including pain reduction, post-stroke rehabilitation, addiction
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12101106 | NEUROLOGICAL STIMULATORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE593638 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
π§πͺ Belgium
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