Myocene
BelgiumFDA applicant, unverified FDA FEI 3036833452
Myocene is a medical device manufacturer, with 3 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 2
- FDA 510(k) 1
- Device classes
- FDA Class II 3
- Identifiers
- FDA FEI 3036833452
- DUNS 372401437
At a glance
Market reach
- United States
- FDA FEI
What Myocene makes
Myocene manufactures a quadriceps fatigue electrostimulation analyser, a device used to assess muscle fatigue through electrical stimulation, and reusable transcutaneous electrical stimulation electrodes for therapeutic applications.
The company’s products are classified as Class II devices under FDA regulations and are listed via 510(k) and UDI pathways.
Catalogue
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
Myocene Ref DEN230051
Regimes: De Novo Registry: De Novo
Company details
- FDA FEI number
- 3036833452
- DUNS number
- 372401437
- Address
- Quai Banning 6, Liege
Frequently asked questions
How many devices does Myocene have in the registry?
The registry currently lists 3 devices for Myocene. Devices recorded under merged duplicate company entries are counted once.
Which registries list Myocene's devices?
Among its 3 most recently registered devices, Myocene has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Myocene's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Myocene's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Myocene in the registry?
The most recently registered devices listed for Myocene include Myocene 1-U, Myocene Electrode 1 and Myocene.