Data / Medical devices / Belgium / Myocene
Myocene: FDA-registered device maker in Liege, Belgium, 2 510(k) clearances
Myocene is registered with the FDA (registration 3036833452) in Liege, Belgium. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036833452
- Address
- Quai Banning 6, Liege, Belgium, 4000
- Owner or operator
- Myocene (10092733)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 12, 2025
- Registered through
- 2026
- Brand names listed
- Myocene Electrode 1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Specification developer | accessdata.fda.gov |
| Neuromuscular Stimulator And Exercise Evaluation System | SDX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 17, 2025 | DEN230051 | Myocene | SDX | Unknown | Myocene | accessdata.fda.gov |
| December 20, 2013 | K132998 | WANDY SELF-ADHESIVE ELECTRODES | GXY | Substantially Equivalent | Wandy Rubber Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 17, 2025. 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.