Identity
- Trade Name
- Evoke® Closed-Loop Stimulator (CLS) EUDAMED
- Device Name
- Evoke® Closed Loop Stimulator (CLS) EUDAMED
- Model / Reference
- 1002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09352307000001 EUDAMED
- Basic UDI-DI
- B-09352307000001 EUDAMED
- EMDN Code
- J02020201 FULLY IMPLANTABLE SPINAL NEUROSTIMULATORS, RECHARGEABLE EUDAMED
Classification
- Device Class
- Class AIMDD EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Evoke® Closed-Loop Stimulator (CLS) by Saluda Medical Pty Ltd — Class AIMDD — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09352307000001 | Class AIMDD | Active |
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Manufacturer
- Manufacturer
- Saluda Medical Pty Ltd
- EUDAMED SRN
- AU-MF-000010522
- Authorised Representative
- MedR-AR Services B.V. NL-AR-000000120
Sources (1)
- EUDAMED ff3760f9-4e14-4b61-a9f7-51075a7651ec 61 fields · synced Aug 1, 2026