# Evoke® Spares Kit

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/evoke-r-spares-kit-1015>
- Manufacturer: [Saluda Medical Pty Ltd](https://devicerts.com/manufacturers/saluda-medical-pty-ltd) (Australia)
- Device class: Active implantable (AIMDD) (EU AIMDD / EU MDR); Class III (EU AIMDD / EU MDR)
- EMDN: J020280 SPINAL IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · MDR 776672 · issued 2026-09-04 · expires 2029-04-08 · status: Active
- **EUDAMED** · CE/AIMDD · European Union · Basic UDI-DI B-09352307000162 · registered 2025-01-21 · status: Active

## EU certificates

- MDR 776672 · Technical documentation · MDR · notified body BSI Group The Netherlands B.V. · issued 2026-09-04 · expires 2029-04-08 · status: supplemented

## Recalls

No recall on record.

## Identity

- Model / reference: 1015 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 09352307000162 [EUDAMED]; 09352307001367 [EUDAMED]
- Basic UDI-DI: B-09352307000162 [EUDAMED]; 935230701015AV [EUDAMED]
- EMDN code: J020280 [EUDAMED]

## Classification

- Device class: Class AIMDD [EUDAMED]; Class III [EUDAMED]
- EU registration type: Legacy device (under a directive) [EUDAMED]; Standard device [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]

## Properties

- Supplied sterile: Yes [EUDAMED]
- Implantable: Yes [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]

## Source and citation

- Cite as: Evoke® Spares Kit, Saluda Medical Pty Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/evoke-r-spares-kit-1015 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/evoke-r-spares-kit-1015.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/evoke-r-spares-kit-1015
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.