Evoke® Spares Kit
Ref 1015
Evoke Spares Kit (1015) is a medical device (EU AIMDD; EU AIMDD Class III; EMDN category spinal implantable neurostimulators - accessories) made by Saluda Medical Pty Ltd, registered in EUDAMED on 21 Jan 2025 (Basic UDI-DI B-09352307000162) with CE/MDR certificate MDR 776672 valid until 8 Apr 2029, active as of 25 Oct 2026.
Active
CE MDR CE AIMDD
Valid until
8 Apr 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 776672 | Date4 Sep 2026 | StatusActive |
| European Union | CE/AIMDD | NumberB-09352307000162 | Date21 Jan 2025 | StatusActive |
Official records
- EUDAMED public site B-09352307000162
Certificates
- MDR 776672 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 4 Sep 2026
- Expires
- 8 Apr 2029
- Reason
- Other
Timeline
- Registered EUDAMED B-09352307000162
- Certificate issued EUDAMED MDR 776672
- Certificate expires EUDAMED MDR 776672
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/AIMDD, CE/MDR Active
Specification
- Model / reference
- 1015
- Primary DI / UDI-DI
- 09352307000162, 09352307001367
- Basic UDI-DI
- B-09352307000162, 935230701015AV
- EMDN code
- J020280 Spinal implantable neurostimulators - accessories
- Device class
- Class AIMDDClass III
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- AU-MF-000010522
- Authorised representative
- MedR-AR Services B.V. NL-AR-000000120
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