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Evoke® Firmware Upgrade Application (FUA)
EUDAMEDClass AIMDD (EU MDR)
Ref 000897
Identity
- Trade Name
- Evoke® Firmware Upgrade Application (FUA) EUDAMED
- Device Name
- Evoke® Firmware Upgrade Application (FUA) EUDAMED
- Model / Reference
- 000897 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-000897M8 EUDAMED
- Basic UDI-DI
- B-000897M8 EUDAMED
- EMDN Code
- J020792 NEUROSTIMULATORS PROGRAMMERS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class AIMDD EUDAMED
- Special Device Type
- -1200 EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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® Firmware Upgrade Application (FUA) by Saluda Medical Pty Ltd — Class AIMDD — MDD, AIMDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/AIMDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-000897M8 | Class AIMDD | Active |
| EUDAMED | European Union | CE/AIMDD | B-000897M8 | 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 d61e4a73-3714-4057-864b-a0d9909929ea 61 fields · synced Jul 13, 2026