EU Manufacturer
🇦🇺 Australia
Active
Saluda Medical Pty Ltd
SRN: AU-MF-000010522
·
Eden Park Drive 5, 2113 Macquarie Park, Australia
Basic UDI-DIs
19
Total Devices
19
On Market
19
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
8
Basic Information
- Address
- Eden Park Drive 5, 2113 Macquarie Park, Australia
- [email protected]
- Website
- www.saludamedical.com
Regulatory Overview
Regulation
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Eu Aimdd
19
Classification
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Eu Aimdd Class
19
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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Market Presence
Devices from this manufacturer are available in 8 countries across Europe.
🇧🇪 Belgium
🇩🇪 Germany
🇪🇸 Spain
🇭🇺 Hungary
🇮🇪 Ireland
🇱🇺 Luxembourg
🇳🇱 Netherlands
🇸🇪 Sweden
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Evoke® 12C Lead Extension Kit - 55cm | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® 12C Percutaneous Lead Kit - 60cm | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® 12C Percutaneous Lead Kit - 90cm | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® 12C Trial Percutaneous Lead Kit - 60cm | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Charger (EU) | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Charger (UK) | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Closed-Loop Stimulator (CLS) | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Epidural Needle, 6.5” | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® External Closed Loop Stimulator (eCLS) | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Spares Kit | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Clinical Data Viewer | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Clinical Programming Application (CPA) | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Pocket Console (EPC) | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® 12C Trial Percutaneous Lead Kit - 90cm | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Charger (AU) | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Clinical System Transceiver (CST) | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Firmware Upgrade Application (FUA) | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Lead Adapter Kit | EU AIMDD | Eu Aimdd Class | On Market | 1 |
| Evoke® Tunnelling Tool | EU AIMDD | Eu Aimdd Class | On Market | 1 |