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Sign in to claim this brandMAINSTAY MEDICAL LIMITED
Ireland·IE-MF-000017550
Last updated May 27, 2026
What MAINSTAY MEDICAL LIMITED makes
Mainstay Medical Limited manufactures implantable neurostimulation systems for chronic pain management, including wired leads for spinal cord and peripheral nerve stimulation, implantable pulse generators, control units, and programming tools. Their portfolio also includes single-use subcutaneous tunnellers for surgical procedures and reusable surgical torque wrenches. Additionally, they produce software for managing implantable electrical stimulation devices and control magnets for active implantable devices.
The company’s devices are regulated under the Active Implantable Medical Device Directive (AIMDD) and fall into Class I and Class III categories. Their products are listed in the EU’s eudamed registry, the FDA’s Premarket Approval (PMA) database, and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in Ireland.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Ireland
- Address
- Clonmel House, Forster Way, County Dublin, Swords, Ireland
- Website
- www.mainstaymedical.com
- —
- —
- [email protected]
- Phone
- +353 830880971
- PRRC Contact
- Sarah Mee
- EUDAMED SRN
- IE-MF-000017550
- FDA FEI Number
- —
- DUNS Number
- 985519015
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ReActiv8 Magnet | 6M4000-004 | FDA UDI | Class III | Active |
| ReActiv8 Stimulation Lead | 7M8145-005 | FDA UDI | Class III | Active |
| ReActiv8 Stimulation Lead | 7M8145-006 | FDA UDI | Class III | Unknown |
| ReActiv8 Programming Wand | 6M6000-002 | FDA UDI | Class III | Active |
| ReActiv8 Programmer | 6M7500-012 | FDA UDI | Class III | Active |
| ReActiv8 Activator | 6M7000-002 | FDA UDI | Class III | Active |
| ReActiv8 Stimulation Lead | 7M8165-005 | FDA UDI | Class III | Active |
| ReActiv8 Release Tool | EXT1 | FDA UDI | Class I | Active |
| ReActiv8 Stimulation Lead | 7M8165-006 | FDA UDI | Class III | Unknown |
| ReActiv8 Programmer | 6M7500-011 | FDA UDI | Class III | Active |
| ReActiv8 Magnet | 6M4000-003 | FDA UDI | Class III | Unknown |
| ReActiv8 IPG | 7M5100-005 | FDA UDI | Class III | Active |
| ReActiv8 Torque Wrench | 7M5500-002 | FDA UDI | Class III | Active |
| Mainstay Tunneler | 7MTUN1-002 | FDA UDI | Class III | Active |
| ReActiv8 Implantable Neurostimulation System | P190021 | FDA PMA | Class III | Active |
| ReActiv8 | 5100 | EUDAMEDFDA UDI | AIMDD | Active |
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