Identity
- Trade Name
- Evoke® 12C Percutaneous Lead Kit - 60cm EUDAMED
- Device Name
- Evoke® 12C Percutaneous Lead Kit - 60cm EUDAMED
- Model / Reference
- 1008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09352307000070 EUDAMED
- Basic UDI-DI
- B-09352307000070 EUDAMED
- EMDN Code
- J020203 SPINAL NEUROSTIMULATION LEADS 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® 12C Percutaneous Lead Kit - 60cm 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-09352307000070 | 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 9f7c9496-a995-4c48-927b-5262cea3ae41 61 fields · synced Jul 19, 2026