Evoke® Tunneler
Ref 1012
Evoke® Tunneler (1012) is a Class III device made by Saluda Medical Pty Ltd, registered in EUDAMED on 7 May 2024 (Basic UDI-DI 935230701012AP) with CE/MDR certificate MDR 776672 valid until 8 Apr 2029, active as of 22 Oct 2026.
Active
CE MDR
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 |
Official records
- EUDAMED public site 935230701012AP
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 935230701012AP
- Certificate issued EUDAMED MDR 776672
- Certificate expires EUDAMED MDR 776672
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- 1012
- Primary DI / UDI-DI
- 09352307001343
- Basic UDI-DI
- 935230701012AP
- EMDN code
- J020280 Spinal implantable neurostimulators - accessories
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- AU-MF-000010522
- Authorised representative
- MedR-AR Services B.V. NL-AR-000000120
Similar devices in this category
Other devices filed under IMPLANTABLE NEUROSTIMULATORS.
- SCS Freedom-4A Permanent Neurostimulator Receiver Kit Channel B FR4A-RCV-B0 by Curonix LLC
- SCS Freedom-4A Trial Neurostimulator Kit Channel A FR4A-TRL-A0 by Curonix LLC
- Inceptiv™ 977119 by MEDTRONIC, INC.
- VNS Therapy® Model 502 Accessory Pack by LivaNova USA, Inc.
- VNS Therapy® PerenniaFLEX® Model 304 Lead 304-30 by LivaNova USA, Inc.
- SenSight™ B31000 by MEDTRONIC, INC.
- Barostim™ Programmer System 100067-201 by Cvrx, Inc.
- Freelink™ SC-5240 by Boston Scientific Neuromodulation