Data / Medical devices / Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring (SEM): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring (product code SEM, Class 2, 21 CFR 882.1360). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on June 11, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SEM
- Device class
- 2
- Regulation
- 882.1360
- Medical specialty
- Neurology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| Australia | 3 |
Makers of Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Epiminder Limited | Melbourne Victoria, Australia | Complaint file establishment, Specification developer | 1 | April 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cochlear Ltd. | LANE COVE New South Wales, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cochlear Ltd | Macquarie University New South Wales, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.