EU Manufacturer
🇨🇭 Switzerland
Active
Aleva Neurotherapeutics SA
SRN: CH-MF-000015804
·
EPFL Innovation Park, Building D, CH-1015 Lausanne, Switzerland
Basic UDI-DIs
13
Total Devices
13
On Market
13
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- EPFL Innovation Park, Building D, CH-1015 Lausanne, Switzerland
- [email protected]
- Website
- www.aleva-neuro.com
Regulatory Overview
Regulation
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Eu Aimdd
13
Classification
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Eu Aimdd Class
13
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| AIMDD Annex II (excluding section 4) | 2223241CE01 | DEKRA Certification B.V. | May 25, 2024 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| directSTIM 12-connector extension | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM 12-electrode lead | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM 24-channel Implantable Pulse Generator | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM Adjustable Harness | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM Charging Paddle | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM Clinician Programmer | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM External Pulse Generator | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM Magnet | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM Patient Programmer Charger kit | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM Port Plug | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM Power Cord | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM Trial Cable | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| directSTIM Tunneling Tool | EU AIMDD | Eu Aimdd Class | On Market | 1 |