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SALUDA MEDICAL PTY LIMITED

Last updated May 24, 2026

What SALUDA MEDICAL PTY LIMITED makes

Saluda Medical produces percutaneous and implantable electrical stimulation systems for spinal cord and peripheral nerve analgesia, including leads, pulse generators, and trial devices. Their portfolio also includes software for device management, neurosurgical kits, soft-tissue anchors, and noninvasive battery chargers. These products are designed for chronic pain management and closed-loop stimulation therapies.

All listed devices fall under Class III regulatory classification in the US, requiring premarket approval (PMA) or de novo clearance. The company’s products are registered in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 744596461

Catalogue (48)

Device	Model / Reference	Registries	Class	Status
Evoke® CAP12 Percutaneous Lead Kit - 90 cm	3009	FDA UDI	Class III	Active
Evoke® 12C Percutaneous Lead Kit - 60 cm	3008	FDA UDI	Class III	Active
Evoke® Closed-Loop Stimulator (CLS)	3002	FDA UDI	Class III	Active
Evoke® Active Anchor Kit	3043	FDA UDI	Class III	Active
Evoke® RECAP® Viewer	3045	FDA UDI	Class III	Active
Evoke® Clinical Interface (CI)	3024	FDA UDI	Class III	Active
Evoke® CAP12 Percutaneous Lead Kit - 90 cm	3009	FDA UDI	Class III	Active
Evoke® Tunnelling Tool	3012	FDA UDI	Class III	Active
Evoke® 12C Percutaneous Trial Lead Kit - 60 cm	3016	FDA UDI	Class III	Active
Evoke® CAP12 Percutaneous Lead Kit - 60 cm	3008	FDA UDI	Class III	Active
Evoke® Spares Kit	3015	FDA UDI	Class III	Active
Evoke® Closed-Loop Stimulator (CLS)	3042	FDA UDI	Class III	Active
Evoke® Clarity® Programming Application	3044	FDA UDI	Class III	Active
Evoke® Active Anchor Kit - L	3043	FDA UDI	Class III	Active
Evoke® Spares Kit	3015	FDA UDI	Class III	Active
Evoke® Clarity™ Programming Application	3044	FDA UDI	Class III	Active
Evoke® CAP12X Lead Extension Kit - 55 cm	3011	FDA UDI	Class III	Active
Evoke® CAP12 Percutaneous Lead Kit - 60 cm	3008	FDA UDI	Class III	Active
Evoke® Spares Kit	3015	FDA UDI	Class III	Active
Evoke® External Closed-Loop Stimulator (eCLS)	3036	FDA UDI	Class III	Active
Evoke® CAP12 Trial Percutaneous Lead Kit - 90 cm	3017	FDA UDI	Class III	Active
Evoke® eCLS Battery Charger Kit	3038	FDA UDI	Class III	Active
Evoke® CAP12 Trial Percutaneous Lead Kit - 60 cm	3016	FDA UDI	Class III	Active
Evoke® CAP12 Percutaneous Lead Kit - 60 cm	3008	FDA UDI	Class III	Active
Evoke® 12C Percutaneous Trial Lead Kit - 90 cm	3017	FDA UDI	Class III	Active
Evoke® 12C Percutaneous Lead Kit - 90 cm	3009	FDA UDI	Class III	Active
Evoke® Patient Controller (EPC)	3040	FDA UDI	Class III	Active
Evoke® Spares Kit	3015	FDA UDI	Class III	Active
Evoke® Clinical Interface (CI)	3024	FDA UDI	Class III	Active
Evoke® External Closed-Loop Stimulator (eCLS) Case	3035	FDA UDI	Class III	Active
Evoke® Intraoperative Cable Kit	3034	FDA UDI	Class III	Active
Evoke® Clinical System Transceiver (CST)	3004	FDA UDI	Class III	Active
Evoke® Closed-Loop Stimulator (CLS)	3042	FDA UDI	Class III	Active
Evoke® RECAP Viewer	3045	FDA UDI	Class III	Active
Evoke ® CAP12 Percutaneous Lead Kit - 60 cm	3008	FDA UDI	Class III	Active
Evoke® CAP12 Percutaneous Lead Kit - 90 cm	3009	FDA UDI	Class III	Active
Evoke® Closed-Loop Stimulator (CLS)	3002	FDA UDI	Class III	Active
Evoke® CAP12 Percutaneous Lead Kit - 90 cm	3009	FDA UDI	Class III	Active
Evoke® CAP12 Trial Percutaneous Lead Kit - 60 cm	3016	FDA UDI	Class III	Active
Evoke® Charger	3006	FDA UDI	Class III	Active
Evoke® CAP12 Trial Percutaneous Lead Kit - 90 cm	3017	FDA UDI	Class III	Active
Evoke® Epidural Needle 6.5"	3014	FDA UDI	Class III	Active
Evoke® Pocket Console (EPC)	3040	FDA UDI	Class III	Active
Evoke® Accessory Belt	3039	FDA UDI	Class III	Active
Evoke® 12C Lead Extension Kit - 55cm	3011	FDA UDI	Class III	Active
Evoke® Spares Kit	3015	FDA UDI	Class III	Active
Evoke® CAP12X Lead Extension Kit - 55 cm	3011	FDA UDI	Class III	Active
Evoke® Active Anchor Kit	3043	FDA UDI	Class III	Active

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